The following data is part of a premarket notification filed by Draeger Medical Gmbh with the FDA for General Purpose Temperature Probe, Skin Temperature Probe.
| Device ID | K121999 |
| 510k Number | K121999 |
| Device Name: | GENERAL PURPOSE TEMPERATURE PROBE, SKIN TEMPERATURE PROBE |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | DRAEGER MEDICAL GMBH 6 TECH DR Andover, MA 01810 |
| Contact | Beth Zis |
| Correspondent | Beth Zis DRAEGER MEDICAL GMBH 6 TECH DR Andover, MA 01810 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-09 |
| Decision Date | 2013-02-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04048675250524 | K121999 | 000 |
| 04048675395515 | K121999 | 000 |
| 04048675250258 | K121999 | 000 |
| 04048675250265 | K121999 | 000 |
| 04048675250272 | K121999 | 000 |
| 04048675250289 | K121999 | 000 |
| 04048675250296 | K121999 | 000 |
| 04048675250500 | K121999 | 000 |
| 04048675250517 | K121999 | 000 |
| 04048675395508 | K121999 | 000 |