FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RECOMED BLOOD-FLOW METER H236-052-02
K Number: K840522
·
Decision May 16, 1985
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
38
Review Days
464
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Basic Information
- Device Name
- RECOMED BLOOD-FLOW METER H236-052-02
- K Number
- K840522
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Litton Medical Electronics
- Date Received
- February 7, 1984
- Decision Date
- May 16, 1985
- Product Code
- DPW
- 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 |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
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Other Clearances by Litton Medical Electronics
| K Number | Device Name | ||
|---|---|---|---|
| K840899 | SERVOMED ARRHYCOMP CENTRAL MONITOR SYS | Nov 20, 1984 | Substantially Equivalent |
| K840439 | RECOMED CARDIAC OUTPUT METER 236067- | 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 |