The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Vital Signs Peep Valve.
Device ID | K802070 |
510k Number | K802070 |
Device Name: | VITAL SIGNS PEEP VALVE |
Classification | Attachment, Breathing, Positive End Expiratory Pressure |
Applicant | VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
Contact | Terence D Wall |
Correspondent | Terence D Wall VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
Product Code | BYE |
CFR Regulation Number | 868.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-08-27 |
Decision Date | 1980-09-09 |