The following data is part of a premarket notification filed by Gulmay Medical Ltd. with the FDA for Darpac 2000 Superficial X-ray Therapy System.
| Device ID | K962613 |
| 510k Number | K962613 |
| Device Name: | DARPAC 2000 SUPERFICIAL X-RAY THERAPY SYSTEM |
| Classification | System, Therapeutic, X-ray |
| Applicant | GULMAY MEDICAL LTD. UNIT 7, SHEPPERTON BUSINESS PARK, GOVETT AVENUE Shepperton, Middlesex, GB Tw17 8ba |
| Contact | G. Condliffe |
| Correspondent | G. Condliffe GULMAY MEDICAL LTD. UNIT 7, SHEPPERTON BUSINESS PARK, GOVETT AVENUE Shepperton, Middlesex, GB Tw17 8ba |
| Product Code | JAD |
| CFR Regulation Number | 892.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-03 |
| Decision Date | 1996-09-27 |