| Device Classification Name |
ventilator, emergency, powered (resuscitator) |
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|---|---|---|---|---|
| 510(k) Number | K991785 | |||
| Device Name | MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR | |||
| Applicant |
|
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| Applicant Contact | tricia wood | |||
| Correspondent |
|
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| Correspodent Contact | tricia wood | |||
| Regulation Number | 868.5925 | |||
| Classification Product Code |
|
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| Date Received | 05/25/1999 | |||
| Decision Date | 08/17/1999 | |||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Anesthesiology |
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| 510k Review Panel |
Anesthesiology |
|||
| statement |
statement |
|||
| Type | Traditional | |||
| Reviewed by Third Party | No | |||
| Combination Product |
No |
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| Recalls | CDRH Recalls |