The following data is part of a premarket notification filed by Inhal-o-tech Medical Plastic with the FDA for Disposable Temperature Probe.
Device ID | K770353 |
510k Number | K770353 |
Device Name: | DISPOSABLE TEMPERATURE PROBE |
Classification | Strip, Temperature, Forehead, Liquid Crystal |
Applicant | INHAL-O-TECH MEDICAL PLASTIC P.O. Box 385 Blue Spring, MO 64015 |
Contact | J.w. Brown |
Correspondent | J.w. Brown INHAL-O-TECH MEDICAL PLASTIC P.O. Box 385 Blue Spring, MO 64015 |
Product Code | KPD |
CFR Regulation Number | 880.2200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-02-22 |
Decision Date | 1977-03-16 |