The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Breas Pv 100 Cpap System.
| Device ID | K001553 |
| 510k Number | K001553 |
| Device Name: | BREAS PV 100 CPAP SYSTEM |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | Anthony P Martino |
| Correspondent | Anthony P Martino VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-18 |
| Decision Date | 2000-08-03 |