FDA 510(k) Applications Submitted by CHRIS MANDER
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K970432 |
02/04/1997 |
INFANT RADIANT WARMER - MODELS IW910 AND IW920 |
FISHER & PAYKEL ELECTRONICS LTD. |
| K030489 |
02/14/2003 |
BRM2 BRAIN MONITOR |
BRAINZ INSTRUMENTS LTD. |
| K180407 |
02/14/2018 |
Smartinhaler |
Adherium (NZ) Ltd |
| K971461 |
04/21/1997 |
SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990) |
FISHER & PAYKEL ELECTRONICS LTD. |
| K211233 |
04/23/2021 |
Hailie Sensor NF0109 |
Adherium (NZ) Ltd |
| K971695 |
05/08/1997 |
SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER |
FISHER & PAYKEL ELECTRONICS LTD. |
| K071449 |
05/24/2007 |
BRM3 BRAIN MONITOR |
BRAINZ INSTRUMENTS LTD. |
| K181405 |
05/29/2018 |
Hailie Sensor |
Adherium (NZ) Ltd |
| K953205 |
05/30/1995 |
CONSTANT CURRENT PERIPHERAL NERVE STIMULATOR NS272 (MODIFICATION) |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K953392 |
07/19/1995 |
HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES) |
FISHER & PAYKEL ELECTRONICS LTD. |
| K982636 |
07/29/1998 |
PATIENT WARMER- MODEL PW810 |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K972885 |
08/05/1997 |
SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970 |
FISHER & PAYKEL ELECTRONICS LTD. |
| K973161 |
08/22/1997 |
CPAP HUMIDIFIER (HC 200) |
FISHER & PAYKEL ELECTRONICS LTD. |
| K983112 |
09/04/1998 |
RESPIRATORY HUMIDIFIER, MODEL # MR850 |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K002839 |
09/12/2000 |
END EXPIRATORY FILTER, MODEL RT020 |
FISHER & PAYKEL HEALTHCARE, LTD. |
| K182573 |
09/18/2018 |
Hailie Sensor |
Adherium (NZ) Ltd |
| K182638 |
09/24/2018 |
Hailie Sensor |
Adherium (NZ) Ltd |
| K033010 |
09/26/2003 |
BRM2 BRAIN MONITOR |
BRAINZ INSTRUMENTS LTD. |
| K173310 |
10/18/2017 |
SmartTouch |
Adherium (NZ) Ltd |
| K163485 |
12/12/2016 |
SmartTouch |
Adherium (NZ) Ltd |
| K003973 |
12/22/2000 |
RESPIRATORY HUMIDIFIER, MODEL HC150 |
FISHER & PAYKEL HEALTHCARE, LTD. |
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