510(k) K875151
K875151 is an FDA 510(k) premarket notification submitted by Endotronics, Inc. for the device "ACUSYST-P/3X". The FDA issued a decision of Substantially Equivalent on January 12, 1988. The device falls under product code KJH (Apparatus, Perfusion), a Class I device regulated under 21 CFR 864.2240. Endotronics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 1988
- Date Received
- December 15, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Perfusion
- Device Class
- Class I
- Regulation Number
- 864.2240
- Review Panel
- PA
- Submission Type