510(k) K770369
K770369 is an FDA 510(k) premarket notification submitted by Diemolding Corp. for the device "VACON TM". The FDA issued a decision of Substantially Equivalent on March 1, 1977. The device falls under product code CBD (Bottle, Collection, Breathing System (Calibrated)), a Class II device regulated under 21 CFR 880.6740. Diemolding Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 1, 1977
- Date Received
- February 24, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bottle, Collection, Breathing System (Calibrated)
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type