The following data is part of a premarket notification filed by Meditech International, Inc. with the FDA for Bioflex Ld-r100 Treatment Head.
| Device ID | K081355 |
| 510k Number | K081355 |
| Device Name: | BIOFLEX LD-R100 TREATMENT HEAD |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | MEDITECH INTERNATIONAL, INC. 411 HORNER AVE., UNIT #1 Toronto, Ontario, CA M8w 4w3 |
| Contact | Fred Kahn |
| Correspondent | Fred Kahn MEDITECH INTERNATIONAL, INC. 411 HORNER AVE., UNIT #1 Toronto, Ontario, CA M8w 4w3 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-14 |
| Decision Date | 2008-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B271LDR1000 | K081355 | 000 |
| B271LDR100P0 | K081355 | 000 |