The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Temperature Probe, Affinity Temperature Probe.
| Device ID | K160091 |
| 510k Number | K160091 |
| Device Name: | Temperature Probe, Affinity Temperature Probe |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | Medtronic, Inc. 7611 Northland Dr. Brooklyn Park, MN 55428 |
| Contact | Choua Thao |
| Correspondent | Choua Thao Medtronic, Inc. 7611 Northland Dr. Brooklyn Park, MN 55428 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-01-15 |
| Decision Date | 2016-05-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169778191 | K160091 | 000 |
| 00643169778184 | K160091 | 000 |
| 00643169778177 | K160091 | 000 |
| 00763000219628 | K160091 | 000 |
| 00763000219635 | K160091 | 000 |
| 00763000219642 | K160091 | 000 |
| 00763000445744 | K160091 | 000 |
| 00763000445737 | K160091 | 000 |
| 00763000445720 | K160091 | 000 |