510(k) K901464
K901464 is an FDA 510(k) premarket notification submitted by Medical Laser, Inc. for the device "MEDILASE SERIES 2200 ENDOSCOPE". The FDA issued a decision of Substantially Equivalent on August 7, 1990. The device falls under product code GCM (Endoscope, Rigid), a Class II device regulated under 21 CFR 876.1500. Medical Laser, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 7, 1990
- Date Received
- March 28, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope, Rigid
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type