The following data is part of a premarket notification filed by Qrsystems, Inc. with the FDA for Qrsystems H.d. Nuclear Imaging Table.
Device ID | K893826 |
510k Number | K893826 |
Device Name: | QRSYSTEMS H.D. NUCLEAR IMAGING TABLE |
Classification | Bed, Scanning, Nuclear |
Applicant | QRSYSTEMS, INC. P.O. BOX 380781 San Antonio, TX 78280 |
Contact | Glenn Smith |
Correspondent | Glenn Smith QRSYSTEMS, INC. P.O. BOX 380781 San Antonio, TX 78280 |
Product Code | IYZ |
CFR Regulation Number | 892.1350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-24 |
Decision Date | 1989-08-02 |