FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO
K Number: K851628
·
Decision Jun 27, 1985
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
77
Applicant Total
15
Review Days
70
Basic Information
- Device Name
- RMG-9 9 REMOTE MONITOR ACCESS. FOR G-2000 ELECTRO
- K Number
- K851628
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- EATON MEDICAL GROUP
- Date Received
- April 18, 1985
- Decision Date
- June 27, 1985
- Product Code
- DXJ
- 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 |
|---|---|---|---|
| DXJ | Display, Cathode-Ray Tube, Medical | FDA class 2 | Cardiovascular |
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Other Clearances by EATON MEDICAL GROUP
| K Number | Device Name | ||
|---|---|---|---|
| K851623 | MODEL TRC-40 TELEMETRY RECIEVER MODULE | Jan 22, 1986 | Substantially Equivalent |
| K851624 | MODEL TT-185 TELEMETRY TRANSMITTER | Jan 14, 1986 | Substantially Equivalent |
| K851625 | SCX-10 SINGLE CHANNEL RECORDER ACCESS. FOR G-2000 | Nov 19, 1985 | Substantially Equivalent |
| K851632 | PCX-100 PATIENT INPUT LEADWIRE | Nov 8, 1985 | Substantially Equivalent |
| K851627 | KBX-20 OUTBOARD KEYBOARD ACCESS. FOR G-2000 ELECTR | 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 |
| 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 |