The following data is part of a premarket notification filed by Helio Medical Supplies, Inc. with the FDA for Firard Ii/ Tdp Lamp.
| Device ID | K960036 |
| 510k Number | K960036 |
| Device Name: | FIRARD II/ TDP LAMP |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | HELIO MEDICAL SUPPLIES, INC. 2080-A WALSH AVE. Santa Clara, CA 95050 |
| Contact | Richard T Koo |
| Correspondent | Richard T Koo HELIO MEDICAL SUPPLIES, INC. 2080-A WALSH AVE. Santa Clara, CA 95050 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-01-02 |
| Decision Date | 1996-06-06 |