FDA 510(k) K920977, MERITRANS(TM) DISPOSABLE TRANSDUCER, by Merit Medical Systems, Inc.
FDA 510(k) K920977, MERITRANS(TM) DISPOSABLE TRANSDUCER, by Merit Medical Systems, Inc.
| 510(k) Number | K920977 |
| Device Classification Name | Transducer, Blood-Pressure, Extravascular |
| Device Name | MERITRANS(TM) DISPOSABLE TRANSDUCER |
| Applicant | Merit Medical Systems, Inc. 79 W. 4500 S., Suite 9 Salt Lake City, UT 84107 |
| Regulation Number | 870.285 |
| Classification Product Code | DRS |
| Date Received | 03/02/1992 |
| Decision Date | 12/11/1992 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Cardiovascular |
| 510k Review Panel | Cardiovascular |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 302 |
| Redacted Pages | 166 |
| Unredacted Pages | 136 |
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