Bottle, Collection, Breathing System (Calibrated)
The Calibrated Breathing System Collection Bottle is a general hospital device used to collect fluids from a patient's breathing system with the added feature of calibrated volume markings, enabling clinical staff to accurately measure the volume of fluid collected. It is classified as FDA Class 2 (moderate risk), though it is exempt from 510(k) premarket notification. The product code is CBD, regulated under 21 CFR 880.6740, within the General Hospital medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- CBD
- Device Class
- FDA class 2
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 3 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K780340 | IMV SYSTEM | Nov 27, 1978 | Substantially Equivalent | Lkb Instruments, Inc. |
| K770665 | VALVE, PRESSURE, DEMAND | Apr 15, 1977 | Substantially Equivalent | Mcgaw Respiratory Therapy |
| K770369 | VACON TM | Mar 01, 1977 | Substantially Equivalent | Diemolding Corp. |
FEI Numbers
This FDA classification entry is associated with 7 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 7 registration numbers. Click on an entry to view related FDA registrations.