FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
P.E.T.
K Number: K812793
·
Decision Jan 18, 1982
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
2
Review Days
104
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
- P.E.T.
- K Number
- K812793
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Hospital Equipment Service
- Date Received
- October 6, 1981
- Decision Date
- January 18, 1982
- 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 Hospital Equipment Service
| K Number | Device Name | ||
|---|---|---|---|
| K812763 | ECG MEDATAPE-601 | Oct 20, 1981 | Substantially Equivalent |