The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Mac/iv Sedation Kit.
| Device ID | K935546 |
| 510k Number | K935546 |
| Device Name: | MAC/IV SEDATION KIT |
| Classification | Gas-machine, Anesthesia |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Jing Zhang |
| Correspondent | Jing Zhang VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-17 |
| Decision Date | 1994-06-13 |