EMERSON MODEL 3HV COMPACT VENTILATOR
FDA 510(k) clearance K862712 · decided 1986-09-18
Clearance details
- K-number
- K862712
- Device name
- EMERSON MODEL 3HV COMPACT VENTILATOR
- Applicant
- J. H. Emerson Co.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-16
- Decision date
- 1986-09-18
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch J. H. Emerson Co.
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.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.