The following data is part of a premarket notification filed by Respironics Novametrix, Llc with the FDA for Philips Nm3 Respiratory Monitor With Ventassist.
| Device ID | K103578 |
| 510k Number | K103578 |
| Device Name: | PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST |
| Classification | Spirometer, Monitoring (w/wo Alarm) |
| Applicant | RESPIRONICS NOVAMETRIX, LLC 5 TECHNOLOGY DRIVE Wallingford, CT 06492 |
| Contact | Kevin Mader |
| Correspondent | Kevin Mader RESPIRONICS NOVAMETRIX, LLC 5 TECHNOLOGY DRIVE Wallingford, CT 06492 |
| Product Code | BZK |
| CFR Regulation Number | 868.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-06 |
| Decision Date | 2011-06-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838083363 | K103578 | 000 |
| 00884838015616 | K103578 | 000 |
| 00884838015630 | K103578 | 000 |
| 00884838015647 | K103578 | 000 |
| 00884838015654 | K103578 | 000 |
| 00884838015678 | K103578 | 000 |
| 00884838015685 | K103578 | 000 |
| 00884838015692 | K103578 | 000 |
| 00884838083349 | K103578 | 000 |
| 00884838083356 | K103578 | 000 |
| 00884838015593 | K103578 | 000 |