510(k) K900472
K900472 is an FDA 510(k) premarket notification submitted by Skytron, Div. the Kmw Group, Inc. for the device "SKYTRON MODEL 860 AND 800 COMP. SURGITA NEURO EQUI". The FDA issued a decision of Substantially Equivalent on September 4, 1990. The device falls under product code HBN (Chair, Neurosurgical), a Class I device regulated under 21 CFR 882.4125. Skytron, Div. the Kmw Group, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 1990
- Date Received
- January 31, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chair, Neurosurgical
- Device Class
- Class I
- Regulation Number
- 882.4125
- Review Panel
- NE
- Submission Type