The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Meritrans(tm) Disposable Transducer.
Device ID | K920977 |
510k Number | K920977 |
Device Name: | MERITRANS(TM) DISPOSABLE TRANSDUCER |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City, UT 84107 |
Contact | Dennis Reigle |
Correspondent | Dennis Reigle MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City, UT 84107 |
Product Code | DRS |
CFR Regulation Number | 870.2850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-02 |
Decision Date | 1992-12-11 |