FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
L.A.P. SPIROMETER
K Number: K864836
·
Decision Mar 6, 1987
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
29
Review Days
87
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
- L.A.P. SPIROMETER
- K Number
- K864836
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Timeter Instrument Corp.
- Date Received
- December 9, 1986
- Decision Date
- March 6, 1987
- Product Code
- BTY
- 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 |
|---|---|---|---|
| BTY | Calculator, Predicted Values, Pulmonary Function | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTY), ordered by most recent decision date.
Ascent Cardiorespiratory Diagnostic Software
FDA 510(k)
FDA Class 2
·Anesthesiology
SpiroSphere, SpiroSphereECG, CardioSphere
FDA 510(k)
FDA Class 2
·Anesthesiology
Pulmonary Function Tester, Model: A9
FDA 510(k)
FDA Class 2
·Anesthesiology
Virtus Metabolic Monitor
FDA 510(k)
FDA Class 2
·Anesthesiology
Model 9100 PFT/DICO
FDA 510(k)
FDA Class 2
·Anesthesiology
MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU
FDA 510(k)
FDA Class 2
·Anesthesiology
Other Clearances by Timeter Instrument Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K875075 | RT-200 COMPUTER INTERFACE | Apr 21, 1988 | Substantially Equivalent |
| K875074 | VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 | Feb 22, 1988 | Substantially Equivalent |
| K871603 | CRITERION II & IIA OXYGEN CONCENTRATORS | Aug 13, 1987 | Substantially Equivalent |
| K834274 | CRITERION I | Apr 13, 1984 | Substantially Equivalent |
| K823775 | BORDON GAGE REGULATOR #BG | Jan 14, 1983 | Substantially Equivalent |
| K822746 | RT-200 CALIBRATION ANALYZER | Oct 13, 1982 | Substantially Equivalent |
| K812766 | PCS-5 ACCESSORIES | Dec 17, 1981 | Substantially Equivalent |
| K813235 | DISS FEMALE AIR ADAPTOR | Dec 8, 1981 | Substantially Equivalent |
| K813234 | OHIO AIR ADAPTOR | Dec 8, 1981 | Substantially Equivalent |
| K812767 | SNIFF AIR COMPRESSOR #SF-6 | Nov 27, 1981 | Substantially Equivalent |