K935441 is an FDA 510(k) clearance for the INFINITECH BREATH EZ. This device is classified as a Table And Attachments, Operating-room (Class I - General Controls, product code BWN).
Submitted by Infinitech, Inc. (St. Louis, US). The FDA issued a Cleared decision on February 7, 1994, 87 days after receiving the submission on November 12, 1993.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4950.
| 510(k) Number | K935441 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 1993 |
| Decision Date | February 07, 1994 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | BWN — Table And Attachments, Operating-room |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4950 |