510(k) K922110
K922110 is an FDA 510(k) premarket notification submitted by Viva-Tek Assoc., Inc. for the device "GO-CLEAN". The FDA issued a decision of Substantially Equivalent on March 9, 1994. The device falls under product code FRR (Chamber, Reverse Isolation, Patient Care), a Class II device regulated under 21 CFR 880.5450. Viva-Tek Assoc., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 1994
- Date Received
- May 5, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chamber, Reverse Isolation, Patient Care
- Device Class
- Class II
- Regulation Number
- 880.5450
- Review Panel
- HO
- Submission Type