The following data is part of a premarket notification filed by Life Medical Services, Inc. with the FDA for Ae 840 Physiological Pressure Transducer.
Device ID | K792020 |
510k Number | K792020 |
Device Name: | AE 840 PHYSIOLOGICAL PRESSURE TRANSDUCER |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | LIFE MEDICAL SERVICES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | DRS |
CFR Regulation Number | 870.2850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-10-09 |
Decision Date | 1979-12-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07071977000082 | K792020 | 000 |
07071977000075 | K792020 | 000 |