FDA 510(k) Applications for Medical Device:
Ventilator, Continuous, Non-Life-Supporting
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K213169 | BMC Medical Co., Ltd. |
Room 901, Building 1, No. 28 Pingguoyuan Road, Shijingshan | Beijing | 100041 | |
| K060546 | BREAS MEDICAL AB |
FORETAGSVAGEN 1 | MOLNLYCKE, VASTRA GOTALAND | SE-435 33 | |
| K240778 | Breas Medical AB |
Foretagsvagen 1 | Molnlycke | 45333 | |
| K962517 | HEALTHDYNE TECHNOLOGIES, INC. |
1850 PARKWAY PLACE | MARIETTA | GA | 30067 |
| K031896 | INNOMED TECHNOLOGIES |
506 GARDEN STREET | GREENSBURG | PA | 15601 |
| K111378 | PHILIPS RESPIRONICS, INC |
1740 GOLDEN MILE HIGHWAY | MONROEVILLE | PA | 15146 |
| K942210 | PURITAN BENNETT CORP. |
10800 PFLUMM RD. | LENEXA | KS | 66215 |
| K974417 | RESMED CORP. |
10121 CAROLL CANYON RD. | SAN DIEGO | CA | 92131 |
| K153061 | RESMED LTD |
1 Elizabeth Macarthur Drive | Bella Vista | 2153 | |
| K161492 | ResMed Ltd |
1 Elizabeth Macarthur Drive | Bella Vista | 2153 | |
| K161487 | ResMed Ltd |
1 Elizabeth Macarthur Drive | Bella Vista | NSW 2153 | |
| K123557 | RESMED LTD. |
9001 SPECTRUM CENTER BLVD. | SAN DIEGO | CA | 92123 |
| K132371 | RESMED LTD. |
9001 SPECTRUM CENTER BLVD. | SAN DIEGO | CA | 92123 |
| K113815 | RESMED LTD. |
9001 SPECTRUM CENTER BLVD. | SAN DIEGO | CA | 92123 |
| K123511 | RESMED LTD. |
9001 SPECTRUM CENTER BLVD. | SAN DIEGO | CA | 92123 |
| K051364 | RESMED LTD. |
14040 DANIELSON ST. | POWAY | CA | 92064-6857 |
| K033276 | RESMED LTD. |
14040 DANIELSON ST. | POWAY | CA | 92064-6857 |
| K093731 | RESMED LTD. |
9001 SPECTRUM CENTER BLVD. | SAN DIEGO | CA | 92123 |
| K060105 | RESMED LTD. |
14040 DANIELSON ST. | POWAY | CA | 92064-6857 |
| K122324 | RESMED LTD. |
9001 SPECTRUM CENTER BLVD. | SAN DIEGO | CA | 92123 |
| K113288 | RESMED LTD. |
9001 SPECTRUM CENTER BLVD. | SAN DIEGO | CA | 92123 |
| K092186 | RESMED LTD. |
9001 SPECTRUM CENTER BLVD. | SAN DIEGO | CA | 92123 |
| K112914 | RESMED LTD. |
9001 SPECTRUM CENTER BLVD. | SAN DIEGO | CA | 92123 |
| K113714 | RESMED LTD. |
9001 SPECTRUM CENTER BLVD. | SAN DIEGO | CA | 92123 |
| K053168 | RESPIRONICS (IRELAND) LIMITED |
PARKMORE BUSINESS PARK, | GALWAY | ||
| K090248 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K090539 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K071509 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K070328 | RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K113053 | RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY | MONROEVILLE | PA | 15146 |
| K063540 | RESPIRONICS, INC. |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K092818 | RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY | MONROEVILLE | PA | 15146 |
| K102465 | RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY | MONROEVILLE | PA | 15146 |
| K984407 | RESPIRONICS, INC. |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K031656 | RESPIRONICS, INC. |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K063533 | RESPIRONICS, INC. |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K092043 | RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY | MONROEVILLE | PA | 15146 |
| K101130 | RESPIRONICS, INC. |
1740 GOLDEN MILE HIGHWAY | MONROEVILLE | PA | 15146 |
| K992530 | RESPIRONICS, INC. |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K012323 | RESPIRONICS, INC. |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K020777 | RESPIRONICS, INC. |
1001 MURRY RIDGE LN. | MURRYSVILLE | PA | 15668 |
| K231064 | SMD Manufacturing LLC |
918 S 500 W, Ste A | Salt Lake City | UT | 84101 |
| K171827 | SMD Manufacturing, LLC |
2500 South State Street, Suite D224 | Salt Lake City | UT | 84115 |
| K093070 | SUNRISE MEDICAL |
100 DEVILBISS DR. | SOMERSET | PA | 15501 |
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