Flowmeter, Calibration, Gas
The Flowmeter, Calibration, Gas is a precision device used to calibrate flowmeters and gas flow measuring instruments employed in respiratory therapy and anesthesia, ensuring measurement accuracy. 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 BXY, regulated under 21 CFR 868.2350 in the Anesthesiology specialty.
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Basic Information
- Product Code
- BXY
- Device Class
- FDA class 1
- Regulation Number
- 868.2350
- 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 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K953506 | WESTMED RESPIRATORY LUER ADAPTOR | Sep 15, 1995 | Substantially Equivalent | Westmed Intl. |
| K902917 | PRECISION MEDICAL ELIMINATOR | Jul 23, 1990 | Substantially Equivalent | Precision Medical, Inc. |
| K902916 | PRECISION MEDICAL NEB BLOCK | Jul 23, 1990 | Substantially Equivalent | Precision Medical, Inc. |
| K863510 | OXY-OFF(TM) | Oct 22, 1986 | Substantially Equivalent | B&B Medical Technologies, Inc. |
| K860516 | LSP MINILATOR | Feb 21, 1986 | Substantially Equivalent | Life Support Products, Inc. |
| K851460 | NEW CONNECTOR & COVER FOR TELECTRONICS 8MM UNIPOLA | May 10, 1985 | Substantially Equivalent | Telectronics, Inc. |
| K781523 | PFT GASES | Dec 01, 1978 | Substantially Equivalent | Gardner Cryogenics |
FEI Numbers
This FDA classification entry is associated with 30 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 30 registration numbers. Click on an entry to view related FDA registrations.