Gas-Flow Meter GFL 10
FDA 510(k) K822820 · Gambro, Inc.
510(k) numberK822820
Submission
- Device name
- Gas-Flow Meter GFL 10
- Applicant
- Gambro, Inc.
Mchenry, IL, US - Received
- September 20, 1982
- Decision date
- October 18, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTX – Gas Control Unit, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K792348 | Stanicor, Omni-Stan,Mod 333B,334A GammaDTX · Traditional | Cordis Corp. | 12/05/1979SE |
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Questions and answers
When was Gas-Flow Meter GFL 10 cleared by the FDA?
Gas-Flow Meter GFL 10 (K822820) received a 510(k) decision of Substantially Equivalent on October 18, 1982, 28 days after the submission was received.
What is the product code of K822820?
The FDA product code is DTX – Gas Control Unit, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4300.