The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Disposable Pressure Manometer.
| Device ID | K022402 |
| 510k Number | K022402 |
| Device Name: | DISPOSABLE PRESSURE MANOMETER |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Contact | David L Najjar |
| Correspondent | David L Najjar VITAL SIGNS, INC. 20 CAMPUS RD. Totowa, NJ 07512 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-23 |
| Decision Date | 2002-08-22 |
| Summary: | summary |