510(k) K884483
K884483 is an FDA 510(k) premarket notification submitted by Orthopedic Systems, Inc. for the device "CRUCIOMETER". The FDA issued a decision of Substantially Equivalent on January 18, 1989. The device falls under product code JZE (Spoon, Ear), a Class I device regulated under 21 CFR 874.4420. Orthopedic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 18, 1989
- Date Received
- October 25, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spoon, Ear
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type