510(k) K820451
K820451 is an FDA 510(k) premarket notification submitted by Imed Corp. for the device "INTRODUCER FOR ENDOTRACHEAL TUBE". The FDA issued a decision of Substantially Equivalent on March 26, 1982. The device falls under product code BWB (Forceps, Tube Introduction), a Class I device regulated under 21 CFR 868.5780. Imed Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 1982
- Date Received
- February 18, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Tube Introduction
- Device Class
- Class I
- Regulation Number
- 868.5780
- Review Panel
- AN
- Submission Type