The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Gould Model Im3000-im3100 Battery Power.
| Device ID | K830885 |
| 510k Number | K830885 |
| Device Name: | GOULD MODEL IM3000-IM3100 BATTERY POWER |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | GOULD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-03-21 |
| Decision Date | 1983-06-22 |