The following data is part of a premarket notification filed by Spectrum X-ray Corp. with the FDA for Spectrum Dg-p7000 Pediatric Cradle.
| Device ID | K933134 |
| 510k Number | K933134 |
| Device Name: | SPECTRUM DG-P7000 PEDIATRIC CRADLE |
| Classification | Cradle, Patient, Radiologic |
| Applicant | SPECTRUM X-RAY CORP. P.O. BOX 155 RYAN AVE. Westville, NJ 08093 |
| Contact | Robert Welsh |
| Correspondent | Robert Welsh SPECTRUM X-RAY CORP. P.O. BOX 155 RYAN AVE. Westville, NJ 08093 |
| Product Code | KXH |
| CFR Regulation Number | 892.1830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-28 |
| Decision Date | 1993-10-07 |