510(k) K760082
K760082 is an FDA 510(k) premarket notification submitted by Inspiron Corp. for the device "BOTTLE, CONDENSATE (#1628)". The FDA issued a decision of Substantially Equivalent on July 16, 1976. The device falls under product code CBC (Bottle, Collection And Trap, Breathing System (Uncalibrated)), a Class II device regulated under 21 CFR 880.6740. Inspiron Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 1976
- Date Received
- June 21, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bottle, Collection And Trap, Breathing System (Uncalibrated)
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type