The following data is part of a premarket notification filed by Lhasa Medical, Inc. with the FDA for Ws-501 Heat Lamp.
| Device ID | K013197 |
| 510k Number | K013197 |
| Device Name: | WS-501 HEAT LAMP |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | LHASA MEDICAL, INC. 234 LIBBEY PKWY. Weymouth, MA 02189 |
| Contact | Kyung P Riihimaki |
| Correspondent | Kyung P Riihimaki LHASA MEDICAL, INC. 234 LIBBEY PKWY. Weymouth, MA 02189 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-25 |
| Decision Date | 2002-08-29 |
| Summary: | summary |