The following data is part of a premarket notification filed by Brattle Instrument Corp. with the FDA for Phipiological Synchronizer Part#205.
Device ID | K781681 |
510k Number | K781681 |
Device Name: | PHIPIOLOGICAL SYNCHRONIZER PART#205 |
Classification | Table, Radiographic, Stationary Top |
Applicant | BRATTLE INSTRUMENT CORP. 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | IXQ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-10-02 |
Decision Date | 1978-10-17 |