Quantum Ventilation Module
FDA 510(k) clearance K202733 · decided 2020-10-16
Clearance details
- K-number
- K202733
- Device name
- Quantum Ventilation Module
- Applicant
- Spectrum Medical , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2020-09-18
- Decision date
- 2020-10-16
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- DTX
- Device class
- 2
- Regulation number
- 870.4300
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Gloucester, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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| Record | Firm | Date |
|---|---|---|
| Quantum Mini Ventilation Module (K210669) | Spectrum Medical , Ltd. | 2021-05-04 |
| Quantum Ventilation Module (K181942) | Spectrum Medical , Ltd. | 2018-10-18 |
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| MODIFIED SARNS MEMBRANE OXYGENATOR (K863902) | 3M Health Care, Sarns | 1986-12-11 |
| GAS-FLOW METER GFL 10 (K822820) | Gambro, Inc. | 1982-10-18 |
| STANICOR, OMNI-STAN,MOD 333B,334A GAMMA (K792348) | Cordis Corp. | 1979-12-05 |
| FLOWMETER, OPTIFLO GAS (K790546) | Cobe Laboratories, Inc. | 1979-05-11 |
Recalls involving this device
No recalls on record reference this clearance.