FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM
K Number: K865101
·
Decision Apr 20, 1987
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
176
Applicant Total
13
Review Days
111
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Basic Information
- Device Name
- SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM
- K Number
- K865101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1435
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Spectramed, Inc.
- Date Received
- December 30, 1986
- Decision Date
- April 20, 1987
- 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 Spectramed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K896122 | AMNICATHDL(TM) DT-IUPC2 DUAL LUMEN TRANS. TIPPED | Jan 19, 1990 | Substantially Equivalent |
| K892941 | CCO SYSTEM MODEL SP1467,SP5567,SP6267 | Nov 6, 1989 | Substantially Equivalent |
| K895323 | MODEL DT-BAL, BALANCE SAVER | Oct 24, 1989 | Substantially Equivalent |
| K894362 | MODEL DT-IUPC2 TRANSDUCER TIPPED DUAL LUMEN IUP | Aug 15, 1989 | Substantially Equivalent |
| K881857 | AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU. | Feb 1, 1989 | Substantially Equivalent |
| K885235 | SAFE-DRAW(TM) BLOOD SAMPLING RESERVOIR & ACCESS. | Jan 25, 1989 | Substantially Equivalent |
| K881825 | MODELS SP5825/SP5835/SP5845/SP5855 PERCU. SHEATH | Sep 28, 1988 | Substantially Equivalent |
| K875337 | HEPARIN COATED LUMINAL PACING CATHETER | May 25, 1988 | Substantially Equivalent |
| K880740 | MODEL TA-CS10 SPECTRAJECT CONTROL SYRINGE | Mar 22, 1988 | Substantially Equivalent |
| K873168 | SPECTRAMED DISPOSABLE TRANSDUCER (DT-XXO) & ACCESS | Jan 12, 1988 | Substantially Equivalent |