CATALOG NO. I/A 100 AND KPE 200
FDA 510(k) clearance K862334 · decided 1986-07-08
Clearance details
- K-number
- K862334
- Device name
- CATALOG NO. I/A 100 AND KPE 200
- Applicant
- Ipax, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-06-10
- Decision date
- 1986-07-08
- Days to decision
- 28 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ipax
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.