MODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)
FDA premarket approval P890057/S014 · decided 2001-09-24
Approval details
- PMA number
- P890057
- Supplement
- S014
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Applicant
- ZOLL Medical Corporation
- Date received
- 2001-02-22
- Decision date
- 2001-09-24
- Days to decision
- 214 days
- Decision code
- APPR
- Product code
- LSZ
- Advisory committee
- Anesthesiology
- Expedited review
- No
- Location
- Chelsmford, MA
- Statement
- APPROVAL FOR THE MODEL 3100B HFOV. THE DEVICE IS INDICATED FOR USE IN THE VENTILATORY SUPPORT AND TREATMENT OF SELECTED PATIENTS 35 KILOGRAMS AND GREATER WITH ACUTE RESPIRATORY FAILURE.
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