FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODULAR MASS SPECTROMETER (M.S.)
K Number: K862605
·
Decision Aug 13, 1986
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
304
Applicant Total
62
Review Days
36
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Basic Information
- Device Name
- MODULAR MASS SPECTROMETER (M.S.)
- K Number
- K862605
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1400
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- The Perkin-Elmer Corp.
- Date Received
- July 8, 1986
- Decision Date
- August 13, 1986
- Product Code
- CCK
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | FDA class 2 | Anesthesiology |
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Other Clearances by The Perkin-Elmer Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K935666 | PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMP | Apr 26, 1994 | Substantially Equivalent |
| K900828 | PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO. | Apr 9, 1990 | Substantially Equivalent |
| K884864 | PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTRO | Feb 10, 1989 | Substantially Equivalent |
| K884886 | MODEL 250 LIQUID CHROMOTAGRAPHY PUMP | Feb 2, 1989 | Substantially Equivalent |
| K872737 | PERKIN-ELMER LC235 DIODE ARRAY DETECTOR | Sep 18, 1987 | Substantially Equivalent |
| K872464 | ION TRAP DETECTOR (ITD) | Aug 11, 1987 | Substantially Equivalent |
| K871550 | PFI-20 POLARIZING FLUORIMETER | Jul 1, 1987 | Substantially Equivalent |
| K872122 | 8000 SERIES GAS CHROMATOGRAPHS | Jun 17, 1987 | Substantially Equivalent |
| K870661 | LIFEWATCH PLUS | Mar 9, 1987 | Substantially Equivalent |
| K862178 | ISOPURE LC SYSTEM | Jul 14, 1986 | Substantially Equivalent |