The following data is part of a premarket notification filed by Cypress Medical Products, Ltd. with the FDA for Clinical Mercury Thermometer.
Device ID | K897054 |
510k Number | K897054 |
Device Name: | CLINICAL MERCURY THERMOMETER |
Classification | Thermometer, Clinical Mercury |
Applicant | CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 Mchenry, IL 60050 |
Contact | Varun Soni |
Correspondent | Varun Soni CYPRESS MEDICAL PRODUCTS, LTD. 1202 SOUTH ROUTE 31 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 | 1989-12-18 |
Decision Date | 1990-03-22 |