510(k) K011725
K011725 is an FDA 510(k) premarket notification submitted by Keymed (Medical & Industrial Equipment), Ltd. for the device "OLYMPUS SUCTION PUMP, MODEL KV-5". The FDA issued a decision of Substantially Equivalent on Aug 31, 2001. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780. Keymed (Medical & Industrial Equipment), Ltd. has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 31, 2001
- Date Received
- Jun 4, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type
- 510(k)