The following data is part of a premarket notification filed by Healthdyne, Inc. with the FDA for Data Recorder.
| Device ID | K910118 |
| 510k Number | K910118 |
| Device Name: | DATA RECORDER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | HEALTHDYNE, INC. 3371 LENORA CHURCH RD. Snellville, GA 30039 |
| Contact | Tim Cowart |
| Correspondent | Tim Cowart HEALTHDYNE, INC. 3371 LENORA CHURCH RD. Snellville, GA 30039 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-11 |
| Decision Date | 1991-02-14 |