The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Downs Vpap Circuit.
| Device ID | K852333 |
| 510k Number | K852333 |
| Device Name: | DOWNS VPAP CIRCUIT |
| Classification | Regulator, Pressure, Gas Cylinder |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Terrence D Wall |
| Correspondent | Terrence D Wall VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | CAN |
| CFR Regulation Number | 868.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-31 |
| Decision Date | 1985-10-16 |