Calibrator, Volume, Gas
The Calibrator, Volume, Gas is a device used to verify and calibrate the volume measurement accuracy of spirometers and other respiratory gas volume measuring instruments in clinical or laboratory settings. It is classified as FDA Class 1, the lowest risk category, subject to general controls only with no premarket submission required. The product code is BXW, regulated under 21 CFR 868.1870 in the Anesthesiology specialty.
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Basic Information
- Product Code
- BXW
- Device Class
- FDA class 1
- Regulation Number
- 868.1870
- Medical Specialty
- Anesthesiology
- Review Panel
- AN
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K853848 | RESPIRATORY DIAGNOSTIC EQUIPMENT CALIBRATOR | Dec 05, 1985 | Substantially Equivalent | Medical Graphics Corp. |
| K831758 | FLOW-CALIBRATION MODULE | Jul 19, 1983 | Substantially Equivalent | The Perkin-Elmer Corp. |
| K830898 | SYRINGE 500BC BE #7000 | May 16, 1983 | Substantially Equivalent | Instrumentation Industries, Inc. |
| K812765 | DATASCRIBE #DS-40 | Nov 16, 1981 | Substantially Equivalent | Timeter Instrument Corp. |
| K810290 | OHIO CAL-CHEK | Feb 12, 1981 | Substantially Equivalent | Ohio Medical Products |
| K760520 | CALIPERS, MCGAW SKINFOLD | Nov 12, 1976 | Substantially Equivalent | Mcgaw Laboratories |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.