FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RMS 111F RESPIRATORY MONITORING SYSTEM
K Number: K800086
·
Decision May 8, 1980
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
60
Applicant Total
62
Review Days
115
Basic Information
- Device Name
- RMS 111F RESPIRATORY MONITORING SYSTEM
- K Number
- K800086
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1850
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- The Perkin-Elmer Corp.
- Date Received
- January 14, 1980
- Decision Date
- May 8, 1980
- Product Code
- BZK
- 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 |
|---|---|---|---|
| BZK | Spirometer, Monitoring (W/Wo Alarm) | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BZK), ordered by most recent decision date.
BEACON Caresystem Model 00002144
FDA 510(k)
FDA Class 2
·Anesthesiology
ExSpiron 2Xi
FDA 510(k)
FDA Class 2
·Anesthesiology
Gas Module 3
FDA 510(k)
FDA Class 2
·Anesthesiology
ExSpiron 1Xi
FDA 510(k)
FDA Class 2
·Anesthesiology
ExSpiron 1Xi
FDA 510(k)
FDA Class 2
·Anesthesiology
EXSPIRON 1XI
FDA 510(k)
FDA Class 2
·Anesthesiology
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 |