The following data is part of a premarket notification filed by Steris Corporation with the FDA for Harmony Led-1 Surgical Lighting System.
| Device ID | K072072 |
| 510k Number | K072072 |
| Device Name: | HARMONY LED-1 SURGICAL LIGHTING SYSTEM |
| Classification | Light, Surgical, Ceiling Mounted |
| Applicant | STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Contact | John Scoville |
| Correspondent | John Scoville STERIS Corporation 5960 Heisley Road Mentor, OH 44060 |
| Product Code | FSY |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-30 |
| Decision Date | 2007-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995151461 | K072072 | 000 |