The following data is part of a premarket notification filed by Meditech International, Inc. with the FDA for Bioflex Prescription System And Related Treatment Heads.
Device ID | K051875 |
510k Number | K051875 |
Device Name: | BIOFLEX PRESCRIPTION SYSTEM AND RELATED TREATMENT HEADS |
Classification | Lamp, Infrared, Therapeutic Heating |
Applicant | MEDITECH INTERNATIONAL, INC. 1151 HOPE ST. Stamford, CT 06907 |
Contact | Richard Keen |
Correspondent | Richard Keen MEDITECH INTERNATIONAL, INC. 1151 HOPE ST. Stamford, CT 06907 |
Product Code | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-07-11 |
Decision Date | 2006-03-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B271SLD1800 | K051875 | 000 |
B271SLD1200 | K051875 | 000 |
B271CUP0 | K051875 | 000 |
B271CU0 | K051875 | 000 |
B271LSB48900 | K051875 | 000 |
B271LSB32700 | K051875 | 000 |
B271ART1800 | K051875 | 000 |