The following data is part of a premarket notification filed by Vital Signs, Inc. with the FDA for Single Use Non-conductive Circ. Discon.
| Device ID | K821667 |
| 510k Number | K821667 |
| Device Name: | SINGLE USE NON-CONDUCTIVE CIRC. DISCON |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
| Contact | Kerry J Savage |
| Correspondent | Kerry J Savage VITAL SIGNS, INC. 1 MADISON ST. East Rutherford, NJ 07073 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-06-07 |
| Decision Date | 1982-06-24 |