The following data is part of a premarket notification filed by Arc Devices Limited with the FDA for Arc Instatemp Non-touch Thermometer, Arc Instatemp Md Non-touch Thermometer.
| Device ID | K152905 |
| 510k Number | K152905 |
| Device Name: | ARC InstaTemp Non-Touch Thermometer, ARC InstaTemp MD Non-Touch Thermometer |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ARC DEVICES LIMITED 2 DEERPARK INDUSTRIAL ESTATE, ORANMORE Galway, IE H91 D72h |
| Contact | Gary Brogan |
| Correspondent | Gary Brogan ARC DEVICES LIMITED 2 DEERPARK INDUSTRIAL ESTATE, ORANMORE Galway, IE H91 D72h |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-01 |
| Decision Date | 2016-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391525574011 | K152905 | 000 |