The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Pediatric Anesthesia Circuit.
Device ID | K801111 |
510k Number | K801111 |
Device Name: | PEDIATRIC ANESTHESIA CIRCUIT |
Classification | Circuit, Breathing (w Connector, Adaptor, Y Piece) |
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 | CAI |
CFR Regulation Number | 868.5240 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-05-12 |
Decision Date | 1980-05-23 |