510(k) K000948
K000948 is an FDA 510(k) premarket notification submitted by Keymed (Medical & Industrial Equipment), Ltd. for the device "OLYMPUS ENDOSCOPIC FLUSHING PUMP MODEL OFP-1". The FDA issued a decision of Substantially Equivalent on May 12, 2000. The device falls under product code FEQ (Pump, Air, Non-Manual, For Endoscope), a Class II device regulated under 21 CFR 876.1500. Keymed (Medical & Industrial Equipment), Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 12, 2000
- Date Received
- March 23, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Air, Non-Manual, For Endoscope
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type