The following data is part of a premarket notification filed by Brattle Instrument Corp. with the FDA for Synchronizer #208.
| Device ID | K810588 |
| 510k Number | K810588 |
| Device Name: | SYNCHRONIZER #208 |
| Classification | Synchronizer, Ecg / Respirator, Radiographic |
| Applicant | BRATTLE INSTRUMENT CORP. 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | IXO |
| CFR Regulation Number | 892.1970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-04 |
| Decision Date | 1981-04-10 |