The following data is part of a premarket notification filed by Gould, Inc. with the FDA for C/pes 9103, Ecg Stress Testing System.
| Device ID | K850113 |
| 510k Number | K850113 |
| Device Name: | C/PES 9103, ECG STRESS TESTING SYSTEM |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | GOULD, INC. 805 LIBERTY LN. Dayton, OH 45449 |
| Contact | Paul L Kittinger |
| Correspondent | Paul L Kittinger GOULD, INC. 805 LIBERTY LN. Dayton, OH 45449 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-14 |
| Decision Date | 1985-02-08 |