K941850 is an FDA 510(k) clearance for the IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE. This device is classified as a Device, Intravascular Catheter Securement (Class I - General Controls, product code KMK).
Submitted by Tnt Moborg Intl. , Ltd. (Buffalo, US). The FDA issued a Cleared decision on July 14, 1994, 91 days after receiving the submission on April 14, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5210.
| 510(k) Number | K941850 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 14, 1994 |
| Decision Date | July 14, 1994 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | KMK — Device, Intravascular Catheter Securement |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5210 |