The following data is part of a premarket notification filed by Technicare Corp. with the FDA for Nuclear Stress Table (nst-1).
Device ID | K800892 |
510k Number | K800892 |
Device Name: | NUCLEAR STRESS TABLE (NST-1) |
Classification | Exerciser, Measuring |
Applicant | TECHNICARE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ISD |
CFR Regulation Number | 890.5360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-18 |
Decision Date | 1980-05-14 |