The following data is part of a premarket notification filed by United Medical Supply Co., Inc. with the FDA for Umsc Holter Monitoring Kit.
Device ID | K872087 |
510k Number | K872087 |
Device Name: | UMSC HOLTER MONITORING KIT |
Classification | Recorder, Magnetic Tape, Medical |
Applicant | UNITED MEDICAL SUPPLY CO., INC. 10570 BRADFORD RD. Littleton, CO 80127 |
Contact | William E Mcclurg |
Correspondent | William E Mcclurg UNITED MEDICAL SUPPLY CO., INC. 10570 BRADFORD RD. Littleton, CO 80127 |
Product Code | DSH |
CFR Regulation Number | 870.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-06-01 |
Decision Date | 1987-06-19 |