The following data is part of a premarket notification filed by X-cel X-ray Corp. with the FDA for M6-m.
Device ID | K930699 |
510k Number | K930699 |
Device Name: | M6-M |
Classification | System, X-ray, Mobile |
Applicant | X-CEL X-RAY CORP. 4220 WALLER DR., P.O. BOX 1857 Crystal Lake, IL 60039 -1857 |
Contact | William Morris |
Correspondent | William Morris X-CEL X-RAY CORP. 4220 WALLER DR., P.O. BOX 1857 Crystal Lake, IL 60039 -1857 |
Product Code | IZL |
CFR Regulation Number | 892.1720 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-02-10 |
Decision Date | 1993-08-09 |