The following data is part of a premarket notification filed by Diagnostic Imaging Specialists Corp. with the FDA for Pb-a Lead-acid Battery Conversion Kit.
| Device ID | K875106 |
| 510k Number | K875106 |
| Device Name: | PB-A LEAD-ACID BATTERY CONVERSION KIT |
| Classification | System, X-ray, Mobile |
| Applicant | DIAGNOSTIC IMAGING SPECIALISTS CORP. 163 ST. MALO ST. St. Malo, Manitoba, CA R0a1t0 |
| Contact | Gelskey, Ph.d. |
| Correspondent | Gelskey, Ph.d. DIAGNOSTIC IMAGING SPECIALISTS CORP. 163 ST. MALO ST. St. Malo, Manitoba, CA R0a1t0 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-14 |
| Decision Date | 1988-02-22 |