The following data is part of a premarket notification filed by Arizant Healthcare Inc. with the FDA for 3m Spoton Temperature Monitoring System.
| Device ID | K120412 |
| 510k Number | K120412 |
| Device Name: | 3M SPOTON TEMPERATURE MONITORING SYSTEM |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | ARIZANT HEALTHCARE INC. 10393 WEST 70TH ST. Eden Prairie, MN 55344 |
| Contact | David Westlin |
| Correspondent | David Westlin ARIZANT HEALTHCARE INC. 10393 WEST 70TH ST. Eden Prairie, MN 55344 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-10 |
| Decision Date | 2012-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00608223901083 | K120412 | 000 |
| 50707387792959 | K120412 | 000 |
| 50608223360007 | K120412 | 000 |
| 50707387775808 | K120412 | 000 |
| 00849593002301 | K120412 | 000 |
| 00849593002318 | K120412 | 000 |
| 00849593002325 | K120412 | 000 |
| 00849593002332 | K120412 | 000 |
| 00707387775810 | K120412 | 000 |
| 00707387775858 | K120412 | 000 |
| 00707387775865 | K120412 | 000 |
| 00707387775964 | K120412 | 000 |
| 00707387775971 | K120412 | 000 |
| 00707387775988 | K120412 | 000 |
| 00707387775995 | K120412 | 000 |
| 00707387782160 | K120412 | 000 |
| 00608223370001 | K120412 | 000 |
| 00608223901076 | K120412 | 000 |
| 50707387792966 | K120412 | 000 |