510(k) K921355
K921355 is an FDA 510(k) premarket notification submitted by Innovators, Inc. for the device "WINGMASTER". The FDA issued a decision of Substantially Equivalent on September 25, 1992. The device falls under product code EHB (Collimator, X-Ray), a Class I device regulated under 21 CFR 872.1840. Innovators, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 25, 1992
- Date Received
- March 20, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Collimator, X-Ray
- Device Class
- Class I
- Regulation Number
- 872.1840
- Review Panel
- RA
- Submission Type