510(k) K924753
K924753 is an FDA 510(k) premarket notification submitted by Bioenterics Corp. for the device "BIOENTRICS ENDOLUMINA ILLUMINATED BOUGIE". The FDA issued a decision of Substantially Equivalent on December 15, 1992. The device falls under product code HMJ (Screen, Tangent, Projection, Battery-Powered), a Class I device regulated under 21 CFR 886.1810. Bioenterics Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 15, 1992
- Date Received
- September 22, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Screen, Tangent, Projection, Battery-Powered
- Device Class
- Class I
- Regulation Number
- 886.1810
- Review Panel
- OP
- Submission Type