The following data is part of a premarket notification filed by Quantum Medical Systems, Inc. with the FDA for Qad-1 Angio Dynograph Ultraso W/5.0 7.5 Mhz Probes.
Device ID | K853217 |
510k Number | K853217 |
Device Name: | QAD-1 ANGIO DYNOGRAPH ULTRASO W/5.0 7.5 MHZ PROBES |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | QUANTUM MEDICAL SYSTEMS, INC. 1040 12TH AVE. Issaquah, WA 98027 |
Contact | Francis G Smith |
Correspondent | Francis G Smith QUANTUM MEDICAL SYSTEMS, INC. 1040 12TH AVE. Issaquah, WA 98027 |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-08-01 |
Decision Date | 1985-12-30 |