510(k) K772424
K772424 is an FDA 510(k) premarket notification submitted by Ercona Corp. for the device "RYUSEI". The FDA issued a decision of Substantially Equivalent on May 9, 1978. The device falls under product code BWJ (Locator, Acupuncture Point), a Class II device regulated under 21 CFR 880.5580. Ercona Corp. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1978
- Date Received
- December 28, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Locator, Acupuncture Point
- Device Class
- Class II
- Regulation Number
- 880.5580
- Review Panel
- HO
- Submission Type