FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER
FDA 510(k) clearance K140062 · decided 2014-10-03
Clearance details
- K-number
- K140062
- Device name
- FSC ANTI-STATIC VALVED COLLAPSIBLE HOLDING CHAMBER
- Applicant
- Fsc Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-01-10
- Decision date
- 2014-10-03
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- NVP
- Device class
- 2
- Regulation number
- 868.5630
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Charlotte, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administe recall (Z-1995-2016) | FSC Laboratories, Inc | 2016-06-15 |