The following data is part of a premarket notification filed by Polymedica Industries, Inc. with the FDA for Medi-aid Basal Thermometer.
Device ID | K952756 |
510k Number | K952756 |
Device Name: | MEDI-AID BASAL THERMOMETER |
Classification | Device, Fertility Diagnostic, Proceptive |
Applicant | POLYMEDICA INDUSTRIES, INC. 581 CONFERENCE PLACE Golden, CO 80401 |
Contact | Julie Chaffee |
Correspondent | Julie Chaffee POLYMEDICA INDUSTRIES, INC. 581 CONFERENCE PLACE Golden, CO 80401 |
Product Code | LHD |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-16 |
Decision Date | 1995-09-25 |