The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Sureview Mqsa Option Kits (model No.'s 377095 & 377096).
Device ID | K944816 |
510k Number | K944816 |
Device Name: | SUREVIEW MQSA OPTION KITS (MODEL NO.'S 377095 & 377096) |
Classification | System, X-ray, Mammographic |
Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Highland Heights, OH 44143 |
Contact | Robert L Turocy |
Correspondent | Robert L Turocy PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Highland Heights, OH 44143 |
Product Code | IZH |
CFR Regulation Number | 892.1710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-29 |
Decision Date | 1995-02-08 |