510(k) K911461
K911461 is an FDA 510(k) premarket notification submitted by Ellman Intl. Mfg., Inc. for the device "SURGITRON". The FDA issued a decision of Substantially Equivalent on April 25, 1991. The device falls under product code GCI (Laryngoscope, Endoscope), a Class II device regulated under 21 CFR 876.1500. Ellman Intl. Mfg., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 1991
- Date Received
- April 3, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laryngoscope, Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- SU
- Submission Type