The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Adjustable Peep Valve.
Device ID | K904874 |
510k Number | K904874 |
Device Name: | ADJUSTABLE PEEP VALVE |
Classification | Attachment, Breathing, Positive End Expiratory Pressure |
Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
Contact | Alberto Velez |
Correspondent | Alberto Velez VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
Product Code | BYE |
CFR Regulation Number | 868.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-10-30 |
Decision Date | 1991-01-08 |