The following data is part of a premarket notification filed by Sheridan Catheter Corp. with the FDA for Clinical Electonic Thermometers.
Device ID | K881368 |
510k Number | K881368 |
Device Name: | CLINICAL ELECTONIC THERMOMETERS |
Classification | Thermometer, Electronic, Clinical |
Applicant | SHERIDAN CATHETER CORP. ROUTE 40 Argyle, NY 12809 |
Contact | Steen, Phd |
Correspondent | Steen, Phd 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 | 1988-06-21 |
Decision Date | 1988-07-13 |