EMERGENCY PORTABLE VENTILATOR
FDA 510(k) clearance K131098 · decided 2014-04-09
Clearance details
- K-number
- K131098
- Device name
- EMERGENCY PORTABLE VENTILATOR
- Applicant
- Allied Healthcare Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-04-18
- Decision date
- 2014-04-09
- Days to decision
- 356 days
- Clearance type
- Traditional
- Product code
- BTL
- Device class
- 2
- Regulation number
- 868.5925
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Saint Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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| T-PIECE RESUSCITATOR (K142096) | Mercury Medical | 2014-10-17 |
| MOVES SLC (K140049) | Thornhill Research, Inc. | 2014-05-29 |
| LIFEBORNE INFANT RESUSCITATOR (K140707) | International Biomedical | 2014-05-28 |
Recalls involving this device
No recalls on record reference this clearance.