The following data is part of a premarket notification filed by Geon Corp. with the FDA for Geon Electronic Thermometer.
Device ID | K952001 |
510k Number | K952001 |
Device Name: | GEON ELECTRONIC THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | GEON CORP. 50 GORDON DR. Syosset, NY 11791 |
Contact | Ilene Mandelbaum |
Correspondent | Ilene Mandelbaum GEON CORP. 50 GORDON DR. Syosset, NY 11791 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-04-28 |
Decision Date | 1996-10-18 |