The following data is part of a premarket notification filed by Medical Positioning, Inc. with the FDA for Q-stress Echo Bed.
Device ID | K021171 |
510k Number | K021171 |
Device Name: | Q-STRESS ECHO BED |
Classification | Electrocardiograph |
Applicant | MEDICAL POSITIONING, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
Contact | Carol Patterson |
Correspondent | Carol Patterson MEDICAL POSITIONING, INC. 21911 ERIE LN. Lake Forest, CA 92630 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-04-12 |
Decision Date | 2002-05-08 |
Summary: | summary |