The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Modified Drager Sphygmomed.
Device ID | K862427 |
510k Number | K862427 |
Device Name: | MODIFIED DRAGER SPHYGMOMED |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | DRAEGER MEDICAL, INC. 148 B. QUARRY RD. Telford, PA 18969 |
Contact | Edward T Griffith |
Correspondent | Edward T Griffith DRAEGER MEDICAL, INC. 148 B. QUARRY RD. Telford, PA 18969 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-26 |
Decision Date | 1987-03-23 |