FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RECOMED CARDIAC OUTPUT METER 236067-
K Number: K840439
·
Decision Nov 20, 1984
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
176
Applicant Total
38
Review Days
293
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Basic Information
- Device Name
- RECOMED CARDIAC OUTPUT METER 236067-
- K Number
- K840439
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1435
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Litton Medical Electronics
- Date Received
- February 1, 1984
- Decision Date
- November 20, 1984
- Product Code
- DXG
- 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 |
|---|---|---|---|
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | FDA class 2 | Cardiovascular |
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Other Clearances by Litton Medical Electronics
| K Number | Device Name | ||
|---|---|---|---|
| K840522 | RECOMED BLOOD-FLOW METER H236-052-02 | May 16, 1985 | Substantially Equivalent |
| K840899 | SERVOMED ARRHYCOMP CENTRAL MONITOR SYS | Nov 20, 1984 | Substantially Equivalent |
| K840523 | SERVOMED PULSE AMPLIFIER MODULE-206- | Oct 29, 1984 | Substantially Equivalent |
| K840524 | SERVOMED BASIC BEDSIDE UNIT SMV 110TP | Oct 26, 1984 | Substantially Equivalent |
| K840209 | SERVOMED MEDIVISION SCOPE SMV-235 | Sep 20, 1984 | Substantially Equivalent |
| K840832 | SERVOMED OXCARDIORE SPIROGRAPH 324/111 | Sep 20, 1984 | Substantially Equivalent |
| K840521 | SERVOMED DIGITAL DISPLAY MODULE | Jun 1, 1984 | Substantially Equivalent |
| K832250 | SERVOMED BASIC BEDSIDE UNIT SMA 102- | Jun 1, 1984 | Substantially Equivalent |
| K832998 | 2-CHANNEL RECORDER | Jun 1, 1984 | Substantially Equivalent |
| K834600 | RECOMB ECG PREAMPLIFIER/206 069 03 | Jun 1, 1984 | Substantially Equivalent |