The following data is part of a premarket notification filed by Spacelabs, Inc. with the FDA for Esophageal Stethoscope Temperature Probe.
| Device ID | K912742 |
| 510k Number | K912742 |
| Device Name: | ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Contact | Raymond W Gifford |
| Correspondent | Raymond W Gifford SPACELABS, INC. 15220 N.E. 40TH ST. P.O. BOX 97013 Redmond, WA 98073 -9713 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-21 |
| Decision Date | 1992-04-20 |