The following data is part of a premarket notification filed by North American Technical Services Corp. with the FDA for E-z Therm 3 Second Thermometer.
Device ID | K932204 |
510k Number | K932204 |
Device Name: | E-Z THERM 3 SECOND THERMOMETER |
Classification | Thermometer, Electronic, Clinical |
Applicant | NORTH AMERICAN TECHNICAL SERVICES CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
Contact | Richard Lanzillotto |
Correspondent | Richard Lanzillotto NORTH AMERICAN TECHNICAL SERVICES CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-06 |
Decision Date | 1994-10-03 |