The following data is part of a premarket notification filed by Quinton, Inc. with the FDA for Quinton Model 710 Stress Electrocardiograph.
Device ID | K945626 |
510k Number | K945626 |
Device Name: | QUINTON MODEL 710 STRESS ELECTROCARDIOGRAPH |
Classification | Electrocardiograph |
Applicant | QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
Contact | Jerome J Freundlich |
Correspondent | Jerome J Freundlich QUINTON, INC. 3303 MONTE VILLA PKWY. Bothell, WA 98021 -8906 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-16 |
Decision Date | 1995-06-28 |