Flowmeter, Nonback-Pressure Compensated, Bourdon Gauge
The Non-Back-Pressure Compensated Bourdon Gauge Flowmeter is an anesthesiology device used to measure and indicate gas flow rates without downstream pressure compensation, using a Bourdon tube pressure gauge mechanism, typically for medical gas delivery in settings where back-pressure variation is not a significant concern. It is classified as FDA Class 1 (lowest risk), subject only to general controls, and is exempt from premarket notification. The product code is CCN, regulated under 21 CFR 868.2300, within the Anesthesiology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- CCN
- Device Class
- FDA class 1
- Regulation Number
- 868.2300
- 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 9 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K934945 | FLOWMETER NIPPLE ADAPTOR | Nov 17, 1993 | Substantially Equivalent | Cardio-Search , Ltd. |
| K920783 | OXYGEN FLOW CONTROLLER | Sep 18, 1992 | Substantially Equivalent | Puritan Bennett Corp. |
| K872038 | NEB-U-VENT | Aug 10, 1987 | Substantially Equivalent | Design Technologies, Inc. |
| K871262 | MODIFIED NOFLO I | Jul 21, 1987 | Substantially Equivalent | Design Technologies, Inc. |
| K863613 | NO-FLO I | Dec 15, 1986 | Substantially Equivalent | Design Technologies, Inc. |
| K863659 | FLOW INTERRUPTION INDICATOR | Oct 15, 1986 | Substantially Equivalent | Salter Labs |
| K863657 | OXYGEN CONSERVATOR | Oct 15, 1986 | Substantially Equivalent | Salter Labs |
| K823775 | BORDON GAGE REGULATOR #BG | Jan 14, 1983 | Substantially Equivalent | Timeter Instrument Corp. |
| K802037 | VITAMIN B12 FOLATE RADIOASSAY | Nov 21, 1980 | Substantially Equivalent | Corning Medical & Scientific |
FEI Numbers
This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.