The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Spacelabs Model 90201 Holter Recorder.
| Device ID | K844940 |
| 510k Number | K844940 |
| Device Name: | SPACELABS MODEL 90201 HOLTER RECORDER |
| Classification | Recorder, Magnetic Tape, Medical |
| Applicant | SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth, CA 91311 |
| Contact | Allen M Hans |
| Correspondent | Allen M Hans SPACELABS, INC. 20550 PRAIRIE ST. Chatsworth, CA 91311 |
| Product Code | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-12-20 |
| Decision Date | 1985-02-14 |