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 |