The following data is part of a premarket notification filed by Altus Medical, Inc. with the FDA for Altus Medical Optional Infrared Handpiece.
| Device ID | K033768 |
| 510k Number | K033768 |
| Device Name: | ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | ALTUS MEDICAL, INC. 821 COWAN RD. Burlingame, CA 94010 |
| Contact | Kathy Maynor |
| Correspondent | Morten Christensen UNDERWRITERS LABORATORIES, INC. 1655 SCOTT BLVD. Santa Clara, CA 95050 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-12-03 |
| Decision Date | 2004-02-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816722022837 | K033768 | 000 |