The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Downs Adjustable Flow Generator.
| Device ID | K831503 |
| 510k Number | K831503 |
| Device Name: | DOWNS ADJUSTABLE FLOW GENERATOR |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| 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 | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-11 |
| Decision Date | 1983-09-12 |