The following data is part of a premarket notification filed by Joel R.l. Ehren Kranz with the FDA for Pee Wee Thermometers.
| Device ID | K853515 |
| 510k Number | K853515 |
| Device Name: | PEE WEE THERMOMETERS |
| Classification | Thermometer, Clinical Color Change |
| Applicant | JOEL R.L. EHREN KRANZ 60 FRANKLIN ST. Morristown, NJ 07960 |
| Contact | Ehren Kran |
| Correspondent | Ehren Kran JOEL R.L. EHREN KRANZ 60 FRANKLIN ST. Morristown, NJ 07960 |
| Product Code | FQZ |
| CFR Regulation Number | 880.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-22 |
| Decision Date | 1985-10-16 |