The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for One-lung Cpap Device.
| Device ID | K901728 |
| 510k Number | K901728 |
| Device Name: | ONE-LUNG CPAP DEVICE |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Alberto Velez |
| Correspondent | Alberto Velez VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-16 |
| Decision Date | 1990-08-14 |