FDA 510(k) Applications for Medical Device:
Chamber, Hyperbaric
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K011592 | AMRON INTERNATIONAL DIVING SUPPLY, INC. |
759 WEST FOURTH AVE. | ESCONDIDO | CA | 92025 |
| K040145 | ATA HYPERBARIC CHAMBER MANUFACTURING |
695-ALPHA STREET | VICTORIA, BC | ||
| K030713 | BAY AREA HYPERSCIENCES, LLC |
18213 SANDY COVE | HOUSTON | TX | 77058 |
| K001121 | ENGINEERED MEDICAL TECHNOLOGY, INC. |
7303 HOUSTON HWY. | VICTORIA | TX | 77902 |
| K020974 | ENVIRONMENTAL TECTONICS CORP. |
125 JAMES WAY | SOUTHAMPTON | PA | 18966-3877 |
| K993010 | ENVIRONMENTAL TECTONICS CORP. |
555 THIRTEENTH STREET, N.W. | WASHINGTON | DC | 20004-1109 |
| K092991 | ENVIRONMENTAL TECTONICS CORP. |
125 JAMES WAY | SOUTHAMPTON | PA | 18966 |
| K240569 | Fink Engineering Pty Ltd |
14 Premier Circuit | Warana | 4575 | |
| K031649 | FINK ENGINEERING PTY LTD |
18111 COPPER RIDGE DRIVE | SAN ANTONIO | TX | 78259 |
| K011565 | GULF COAST HYPERBARICS, INC. |
4309 GREEN LEAF CIRCLE | PANAMA CITY | FL | 32404 |
| K082455 | GULF COAST HYPERBARICS, INC. |
1100 WEST 26TH ST. | LYNN HAVEN | FL | 32444 |
| K984313 | HYOX SYSTEMS LTD. |
555 THIRTEENTH STREET, NW | WASHINGTON | DC | 20004-1109 |
| K081506 | HYPERBARIC AMERICA, LLC |
1811 COPPER RIDGE DR. | SAN ANTONIO | TX | 78259 |
| K041007 | HYPERBARIC FOR LIFE LLC |
3206 WEST STATE AVE. | PHOENIX | AZ | 85051 |
| K001409 | HYPERBARIC TECHNOLOGIES, INC. |
6329 W. WATERVIEW CT. | MCCORDSVILLE | IN | 46055-9501 |
| K011866 | HYPERBARIC TECHNOLOGIES, INC. |
3224 HOOVER AVE. | NATIONAL CITY | CA | 91950 |
| K002794 | HYPERTEC, INC. |
PO BOX 7007 | DEERFIELD | IL | 60015 |
| K002795 | HYPERTEC, INC. |
PO BOX 7007 | DEERFIELD | IL | 60015 |
| K011312 | KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR |
1811 COPPER RIDGE DR. | SAN ANTONIO | TX | 78259-3612 |
| K060739 | KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR |
PO BOX 7007 | DEERFIELD | IL | 60015 |
| K955535 | LOUISVILLE LABORATORIES, INC. |
2400 CRITTENDEN DR. | LOUISVILLE | KY | 40217-1865 |
| K030418 | MAKAI MARINE INDUSTRIES, INC. |
P.O. BOX 272039 | BOCA RATON | FL | 33427 |
| K022214 | MECHIDYNE SYSTEMS, INC. |
P.O. BOX 840661 | HOUSTON | TX | 77284-0661 |
| K951044 | NTH SYSTEMS, INC. |
1208 SAFARI | SAN ANTONIO | TX | 78216 |
| K171899 | Oxavita S.R.L. |
Tamborini 5813 | Buenos Aires | ||
| K052866 | OXYHEAL HEALTH GROUP |
3224 HOOVER AVE. | NATIONAL CITY | CA | 91950 |
| K163109 | OXYHEAL MEDICAL SYSTEMS, INC. |
3224 HOOVER AVE | NATIONAL CITY | CA | 91950 |
| K152223 | OXYHEAL MEDICAL SYSTEMS, INC. |
3224 HOOVER AVE. | National City | CA | 91950 |
| K021690 | PAN-AMERICA HYPERBARICS, INC. |
18111 COPPER RIDGE DR. | SAN ANTONIO | TX | 78259-3612 |
| K021693 | PAN-AMERICA HYPERBARICS, INC. |
18111 COPPER RIDGE DR. | SAN ANTONIO | TX | 78259-3612 |
| K021689 | PAN-AMERICA HYPERBARICS, INC. |
18111 COPPER RIDGE DR. | SAN ANTONIO | TX | 78259-3612 |
| K051759 | PERFORMANCE HYPERBARICS |
2599 A OLINDA ROAD | MAKAWAO | HI | 96768 |
| K990927 | PERRY BAROMEDICAL CORP. |
3660 INTERSTATE PKWY. | RIVERA BEACH | FL | 33404 |
| K974868 | PERRY BAROMEDICAL CORP. |
7555 GARDEN RD. | RIVIERA BEACH | FL | 33404 |
| K072427 | PERRY BAROMEDICAL CORP. |
3660 INTERSTATE PKWY. | RIVIERA BEACH | FL | 33404 |
| K983648 | PERRY BAROMEDICAL SERVICES |
7555 GARDEN RD. | RIVIERA BEACH | FL | 33404 |
| K101262 | PRESSURE-TECH, INC. |
55 Northern Blvd | Great Neck | NY | 11021 |
| K962869 | REIMERS SYSTEMS, INC. |
7668 FULLERTON RD., SUITE I-4 | SPRINGFIELD | VA | 22153 |
| K962871 | REIMERS SYSTEMS, INC. |
7668 FULLERTON RD., SUITE I-4 | SPRINGFIELD | VA | 22153 |
| K102831 | REIMERS SYSTEMS, INC. |
8210-D CINDERBED RD. | LORTON | VA | 22079 |
| K972908 | SANDS HYPERBARICS |
709 EAST WASHINGTON BLVD. | LOS ANGELES | CA | 90021 |
| K010659 | SEA-LONG MEDICAL SYSTEMS, INC. |
1983 SOUTH PARK RD. | LOUISVILLE | KY | 40219 |
| K052713 | SECHRIST INDUSTRIES, INC. |
4225 EAST LA PALMA AVE. | ANAHEIM | CA | 92807 |
| K100268 | SECHRIST INDUSTRIES, INC. |
4225 EAST LA PALMA AVE. | ANAHEIM | CA | 92807 |
| K140559 | SECHRIST INDUSTRIES, INC. |
4225 EAST LA PALMA AVE. | ANAHEIM | CA | 92807 |
| K072757 | SUMMIT TO SEA |
1744 AVOCET LANE | MOUND | MN | 55364 |
| K960389 | TAMPA HYPERBARIC ENT. |
700 WEST WATERS AVE. | TAMPA | FL | 33604 |
| K981938 | TAMPA HYPERBARIC ENT. |
700 WEST WATERS AVE. | TAMPA | FL | 33604 |
| K220290 | US Hyperbaric Network |
7600 NW 69th Ave | Medley | FL | 33166 |
| K053498 | WJO, INC |
424 MILL STREET AT CANAL'S END | BRISTOL | PA | 19007 |
| K952545 | WRIGHT INDUSTRIES |
13760 SOUTH GRAMERCY PLACE | GARDENA | CA | 90249 |
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