The following data is part of a premarket notification filed by Acme Portable Machines, Inc. with the FDA for Quantitative Electrocardiographic Detector (qed 2000).
Device ID | K152135 |
510k Number | K152135 |
Device Name: | Quantitative Electrocardiographic Detector (QED 2000) |
Classification | Electrocardiograph |
Applicant | ACME Portable Machines, Inc. 1330 Mountain View Circle Azusa, CA 91702 |
Contact | James Cheng |
Correspondent | James Cheng ACME Portable Machines, Inc. 1330 Mountain View Circle Azusa, CA 91702 |
Product Code | DPS |
CFR Regulation Number | 870.2340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-07-31 |
Decision Date | 2016-08-09 |
Summary: | summary |