510(k) K930852
K930852 is an FDA 510(k) premarket notification submitted by Keymed (Medical & Industrial Equipment), Ltd. for the device "OLYMPUS SUCTION PUMP MODEL KV-4". The FDA issued a decision of Substantially Equivalent on March 31, 1994. 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 at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 31, 1994
- Date Received
- February 18, 1993
- 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