The following data is part of a premarket notification filed by Intec Medical, Inc. with the FDA for Disposable Adult Vo. Ventilator Circuit.
| Device ID | K823271 |
| 510k Number | K823271 |
| Device Name: | DISPOSABLE ADULT VO. VENTILATOR CIRCUIT |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | INTEC MEDICAL, INC. 22200 E. 40 HWY Blue Springs, MO 64015 |
| Contact | Joseph W Brown |
| Correspondent | Joseph W Brown INTEC MEDICAL, INC. 22200 E. 40 HWY Blue Springs, MO 64015 |
| Product Code | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-02 |
| Decision Date | 1982-12-22 |