The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Cardiac Electrophysical Lead Selector, Modified.
| Device ID | K911935 |
| 510k Number | K911935 |
| Device Name: | CARDIAC ELECTROPHYSICAL LEAD SELECTOR, MODIFIED |
| Classification | Amplifier And Signal Conditioner, Biopotential |
| Applicant | GOULD, INC. 8333 ROCKSIDE RD. Valley View, OH 44125 |
| Contact | Robert J Dugan |
| Correspondent | Robert J Dugan GOULD, INC. 8333 ROCKSIDE RD. Valley View, OH 44125 |
| Product Code | DRR |
| CFR Regulation Number | 870.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-01 |
| Decision Date | 1991-07-22 |