The following data is part of a premarket notification filed by Ems Medical, Inc. with the FDA for A10 Ultrascope Recorder.
Device ID | K890142 |
510k Number | K890142 |
Device Name: | A10 ULTRASCOPE RECORDER |
Classification | Recorder, Paper Chart |
Applicant | EMS MEDICAL, INC. 302 LINDBERGH AVE. LIVERMORE, CA 94550 |
Contact | PAUL ULBRICH |
Correspondent | PAUL ULBRICH EMS MEDICAL, INC. 302 LINDBERGH AVE. LIVERMORE, CA 94550 |
Product Code | DSF |
CFR Regulation Number | 870.2810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-01-13 |
Decision Date | 1989-02-06 |