The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Disposable Anesthesia Breathing Circuit, Modified.
| Device ID | K922479 |
| 510k Number | K922479 |
| Device Name: | DISPOSABLE ANESTHESIA BREATHING CIRCUIT, MODIFIED |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Contact | Pope |
| Correspondent | Pope INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
| Product Code | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-26 |
| Decision Date | 1992-10-30 |