The following data is part of a premarket notification filed by Novametrix Medical Systems, Inc. with the FDA for Novametrix Cpap Nasal Cannula.
Device ID | K792722 |
510k Number | K792722 |
Device Name: | NOVAMETRIX CPAP NASAL CANNULA |
Classification | Ventilator, Non-continuous (respirator) |
Applicant | NOVAMETRIX MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BZD |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-12-31 |
Decision Date | 1980-01-24 |