FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRASONIC FLOWMETER
K Number: K800087
·
Decision Mar 19, 1980
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
6
Applicant Total
62
Review Days
65
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ULTRASONIC FLOWMETER
- K Number
- K800087
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.2885
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- The Perkin-Elmer Corp.
- Date Received
- January 14, 1980
- Decision Date
- March 19, 1980
- Product Code
- BXP
- 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 |
|---|---|---|---|
| BXP | Transducer, Gas Flow | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BXP), ordered by most recent decision date.
UNIPOWER RECHARGEABLE BATTERY PACK
FDA 510(k)
FDA Class 1
·Anesthesiology
TIMOX OXYGEN TIMER
FDA 510(k)
FDA Class 1
·Anesthesiology
PHONATORY FUNCTION ANALYZER PS-77
FDA 510(k)
FDA Class 1
·Anesthesiology
OXY-ON DIGITAL OXYGEN TIMER
FDA 510(k)
FDA Class 1
·Anesthesiology
OXYGEN TWMER, MODEL SST
FDA 510(k)
FDA Class 1
·Anesthesiology
ARIZONA OXYGEN TIMER DEVICE
FDA 510(k)
FDA Class 1
·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 |