FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LIFE WATCH RESPIRATORY MONITOR
K Number: K853840
·
Decision Dec 9, 1985
Classifications
1
FEI Numbers
34
Registration Numbers
34
Same Product Code
187
Applicant Total
62
Review Days
84
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Basic Information
- Device Name
- LIFE WATCH RESPIRATORY MONITOR
- K Number
- K853840
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1120
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- The Perkin-Elmer Corp.
- Date Received
- September 16, 1985
- Decision Date
- December 9, 1985
- Product Code
- CHL
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | FDA class 2 | Clinical Chemistry |
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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 |
| K862605 | MODULAR MASS SPECTROMETER (M.S.) | Aug 13, 1986 | Substantially Equivalent |