The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Compact Mask.
| Device ID | K932347 |
| 510k Number | K932347 |
| Device Name: | COMPACT MASK |
| Classification | Mask, Oxygen, Non-rebreathing |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Charles Klein |
| Correspondent | Charles Klein VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | KGB |
| CFR Regulation Number | 868.5570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-14 |
| Decision Date | 1994-01-10 |