PMA P890057S014
- Device
- MODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)
- Applicant
- ZOLL Medical Corporation
- PMA number
- P890057
- Supplement
- S014
- Product code
- LSZ
- Decision date
- 2001-09-24
- Classification
- Ventilator, High Frequency
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Approval order 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.
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf/P890057S014B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- MODEL 3100B HIGH FREQUENCY OSCILLATORY VENTILATOR (HFOV)
- Applicant
- ZOLL Medical Corporation
- PMA number
- P890057
- Supplement
- S014
- Product code
- LSZ
- Generic name
- VENTILATOR, HIGH FREQUENCY
- Decision date
- 2001-09-24
- Decision code
- APPR
- Date received
- 2001-02-22
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order 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.