510(k) K934084
K934084 is an FDA 510(k) premarket notification submitted by Bioenterics Corp. for the device "BIOENTERICS ENDOLUMINA ILLUMINATING BOUGIE". The FDA issued a decision of Substantially Equivalent on December 16, 1993. 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 16, 1993
- Date Received
- August 20, 1993
- 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