510(k) K860838
K860838 is an FDA 510(k) premarket notification submitted by Inspiron Corp. for the device "INSPIRON DOUBLE SWIVEL TRACH ADAPTER". The FDA issued a decision of Substantially Equivalent on April 9, 1986. The device falls under product code BZA (Connector, Airway (Extension)), a Class I device regulated under 21 CFR 868.5810. Inspiron Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 1986
- Date Received
- March 5, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Connector, Airway (Extension)
- Device Class
- Class I
- Regulation Number
- 868.5810
- Review Panel
- AN
- Submission Type