The following data is part of a premarket notification filed by Aequitron Medical, Inc. with the FDA for Model 9101 Recorder/analyzer System.
| Device ID | K901251 |
| 510k Number | K901251 |
| Device Name: | MODEL 9101 RECORDER/ANALYZER SYSTEM |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
| Contact | Kenneth B Herland |
| Correspondent | Kenneth B Herland AEQUITRON MEDICAL, INC. 14800 28TH AVE. NORTH Minneapolis, MN 55447 -4834 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-16 |
| Decision Date | 1990-05-22 |