The following data is part of a premarket notification filed by Kaz Usa, Inc (a Subsidiary Of Kaz Inc) with the FDA for No Touch+forehead Ntf 3000 Thermometer.
| Device ID | K134043 |
| 510k Number | K134043 |
| Device Name: | NO TOUCH+FOREHEAD NTF 3000 THERMOMETER |
| Classification | Thermometer, Electronic, Clinical |
| Applicant | KAZ USA, INC (A SUBSIDIARY OF KAZ INC) 250 TURNPIKE ROAD Southborough, MA 01772 |
| Contact | Raj Kasbekar |
| Correspondent | Raj Kasbekar KAZ USA, INC (A SUBSIDIARY OF KAZ INC) 250 TURNPIKE ROAD Southborough, MA 01772 |
| Product Code | FLL |
| CFR Regulation Number | 880.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-31 |
| Decision Date | 2014-05-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00328785000559 | K134043 | 000 |