The following data is part of a premarket notification filed by Meditech International, Inc. with the FDA for Bioflex Ld-175 And Ld-1200 Treatment Heads.
Device ID | K041885 |
510k Number | K041885 |
Device Name: | BIOFLEX LD-175 AND LD-1200 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 | 2004-07-12 |
Decision Date | 2005-02-24 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B271LDI2000 | K041885 | 000 |
B271LDI200P0 | K041885 | 000 |