NEWPORT VENTILATOR MODEL E-100
FDA 510(k) clearance K852108 · decided 1985-09-18
Clearance details
- K-number
- K852108
- Device name
- NEWPORT VENTILATOR MODEL E-100
- Applicant
- Newport Medical Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-05-15
- Decision date
- 1985-09-18
- Days to decision
- 126 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Newport Beach, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Newport Medical Instruments
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.