The following data is part of a premarket notification filed by Biocare Systems, Inc. with the FDA for Biocare Systems Premir 818.
| Device ID | K042532 |
| 510k Number | K042532 |
| Device Name: | BIOCARE SYSTEMS PREMIR 818 |
| Classification | Lamp, Infrared, Therapeutic Heating |
| Applicant | BIOCARE SYSTEMS, INC. 518 17TH STREET SUITE 1350 Denver, CO 80202 |
| Contact | Clay Anselmo |
| Correspondent | Clay Anselmo BIOCARE SYSTEMS, INC. 518 17TH STREET SUITE 1350 Denver, CO 80202 |
| Product Code | ILY |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-17 |
| Decision Date | 2004-12-13 |
| Summary: | summary |