FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEARTRAK
K Number: K943124
·
Decision May 3, 1995
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
8
Review Days
308
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HEARTRAK
- K Number
- K943124
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Universal Medical, Inc.
- Date Received
- June 29, 1994
- Decision Date
- May 3, 1995
- Product Code
- DXH
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXH | Transmitters And Receivers, Electrocardiograph, Telephone | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DXH), ordered by most recent decision date.
PreemptiveAI Clinical SDK
FDA 510(k)
FDA Class 2
·Cardiovascular
HeartBeam AIMIGo with 12-L ECG Synthesis Software System
FDA 510(k)
FDA Class 2
·Cardiovascular
MEMO Patch M (MPT-E08R-UNC01)
FDA 510(k)
FDA Class 2
·Cardiovascular
Hexoskin Medical System (7100-00016)
FDA 510(k)
FDA Class 2
·Cardiovascular
VitalSigns 1-Lead Holter (VSH101)
FDA 510(k)
FDA Class 2
·Cardiovascular
QT ECG (QTERD100)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Universal Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K083535 | HEARTRAK SMART ECAT | Dec 15, 2008 | Substantially Equivalent |
| K071130 | HEARTRAK AF | May 14, 2008 | Substantially Equivalent |
| K033451 | HEARTRAK SMART AT/HEARTRAK SMART2 | Feb 5, 2004 | Substantially Equivalent |
| K980624 | CARDIOSTATION | May 11, 1998 | Substantially Equivalent |
| K960499 | HEARTRAK XL | Aug 6, 1996 | Substantially Equivalent |
| K954495 | PACETRAK PLUS | Apr 22, 1996 | Substantially Equivalent |
| K943123 | PACETRAK | May 3, 1995 | Substantially Equivalent |