510(k) K834070
K834070 is an FDA 510(k) premarket notification submitted by Paragon Diagnostics, Inc. for the device "IMMPULSE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 23, 1984. The device falls under product code JZT (Fluorometer), a Class I device regulated under 21 CFR 866.4520. Paragon Diagnostics, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1984
- Date Received
- November 25, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluorometer
- Device Class
- Class I
- Regulation Number
- 866.4520
- Review Panel
- IM
- Submission Type