VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
FDA 510(k) clearance K041473 · decided 2004-07-15
Clearance details
- K-number
- K041473
- Device name
- VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
- Applicant
- Vortran Medical Technology 1, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-06-02
- Decision date
- 2004-07-15
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- BTL
- Device class
- 2
- Regulation number
- 868.5925
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| VORTRAN Automatic Resuscitator, VARPlus; Model PTE-5002; Qty: 10 each Anesthesiology: This recall (Z-2091-2017) | Vortran Medical Technology 1, Inc | 2017-04-25 |
| VORTRAN Automatic Resuscitator, VARPlus with Extension Kit; Model PCE-5012; Qty: 10 each. recall (Z-2092-2017) | Vortran Medical Technology 1, Inc | 2017-04-25 |