The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Non Conductive Pediatric Anes. Face.
| Device ID | K821045 |
| 510k Number | K821045 |
| Device Name: | NON CONDUCTIVE PEDIATRIC ANES. FACE |
| Classification | Mask, Gas, Anesthetic |
| Applicant | VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
| Contact | Kerry J Savage |
| Correspondent | Kerry J Savage VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
| Product Code | BSJ |
| CFR Regulation Number | 868.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-04-14 |
| Decision Date | 1982-04-26 |