FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL TT-185 TELEMETRY TRANSMITTER
K Number: K851624
·
Decision Jan 14, 1986
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
296
Applicant Total
15
Review Days
271
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
- MODEL TT-185 TELEMETRY TRANSMITTER
- K Number
- K851624
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2920
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Eaton Medical Group
- Date Received
- April 18, 1985
- Decision Date
- January 14, 1986
- 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 Eaton Medical Group
| K Number | Device Name | ||
|---|---|---|---|
| K851623 | MODEL TRC-40 TELEMETRY RECIEVER MODULE | Jan 22, 1986 | Substantially Equivalent |
| K851625 | SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000 | Nov 19, 1985 | Substantially Equivalent |
| K851627 | KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR | Nov 8, 1985 | Substantially Equivalent |
| K851632 | PCX-100 PATIENT INPUT LEADWIRE | Nov 8, 1985 | Substantially Equivalent |
| K851631 | TMX-C1/C2 TRADMILL CONTROLLER ACCESS. | Jul 15, 1985 | Substantially Equivalent |
| K851630 | TMX-80 TREADMILL | Jul 9, 1985 | Substantially Equivalent |
| K851629 | TMX-70 TREADMILL | Jul 9, 1985 | Substantially Equivalent |
| K851628 | RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO | Jun 27, 1985 | Substantially Equivalent |
| K851626 | SCX-35 THREE CHANNEL ACCESS. FOR MODULE G-2000 ELE | Jun 26, 1985 | Substantially Equivalent |
| K851633 | CC-100 CLOCK/CALANDER MODULE ACCESS. FOR G-2000 EL | Jun 26, 1985 | Substantially Equivalent |