The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Clinical Electronic Thermometers.
Device ID | K884765 |
510k Number | K884765 |
Device Name: | CLINICAL ELECTRONIC THERMOMETERS |
Classification | Thermometer, Electronic, Clinical |
Applicant | SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
Contact | Steen, Ph.d. |
Correspondent | Steen, Ph.d. SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-11-14 |
Decision Date | 1989-02-16 |