The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Balloon Thermodilution Catheter.
Device ID | K881893 |
510k Number | K881893 |
Device Name: | NUMED BALLOON THERMODILUTION CATHETER |
Classification | Probe, Thermodilution |
Applicant | NUMED, INC. MAIN ST. Hopkinton, NY 12940 |
Contact | Allen J Tower |
Correspondent | Allen J Tower NUMED, INC. MAIN ST. Hopkinton, NY 12940 |
Product Code | KRB |
CFR Regulation Number | 870.1915 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-05 |
Decision Date | 1988-09-06 |