The following data is part of a premarket notification filed by Smi with the FDA for Spectropad System.
| Device ID | K931261 |
| 510k Number | K931261 |
| Device Name: | SPECTROPAD SYSTEM |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | SMI 11111 D WEST 8TH AVE. Lakewood, CO 80215 |
| Contact | Joe Markham |
| Correspondent | Joe Markham SMI 11111 D WEST 8TH AVE. Lakewood, CO 80215 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-12 |
| Decision Date | 1994-03-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00859101006097 | K931261 | 000 |
| 00859101006042 | K931261 | 000 |
| 00859101006035 | K931261 | 000 |
| 00859101006028 | K931261 | 000 |
| 00859101006011 | K931261 | 000 |
| 00859101006004 | K931261 | 000 |
| 00859101006103 | K931261 | 000 |