The following data is part of a premarket notification filed by Narco Air-shields with the FDA for Valve, Ambu Peep.
Device ID | K782152 |
510k Number | K782152 |
Device Name: | VALVE, AMBU PEEP |
Classification | Attachment, Breathing, Positive End Expiratory Pressure |
Applicant | NARCO AIR-SHIELDS Houston, TN 77061 |
Contact | Unknown Unknown |
Correspondent | Unknown Unknown NARCO AIR-SHIELDS Houston, TX 77061 |
Product Code | BYE |
CFR Regulation Number | 868.5965 [🔎] |
Decision | Se - Postmarket Surveillance Required (SESP) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-12-26 |
Decision Date | 1978-12-26 |