FLOW CONTROLLER
FDA 510(k) clearance K843223 · decided 1984-09-27
Clearance details
- K-number
- K843223
- Device name
- FLOW CONTROLLER
- Applicant
- Precision Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-08-16
- Decision date
- 1984-09-27
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- BTM
- Device class
- 2
- Regulation number
- 868.5915
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PM1000 Flow Selector - An accessory to an emergency ventilator (resuscitator). The selecto recall (Z-1561-2010) | Precision Medical, Inc. | 2010-05-09 |