The following data is part of a premarket notification filed by Hudson Oxygen Therapy Sales Co. with the FDA for Disposable Thermometers.
Device ID | K822502 |
510k Number | K822502 |
Device Name: | DISPOSABLE THERMOMETERS |
Classification | Thermometer, Clinical Mercury |
Applicant | HUDSON OXYGEN THERAPY SALES CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FLK |
CFR Regulation Number | 880.2920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-08-23 |
Decision Date | 1982-09-24 |