510(k) K881467
K881467 is an FDA 510(k) premarket notification submitted by Cryodyne Technologies, Inc. for the device "MICROSCOPE STAGE HEATER". The FDA issued a decision of Substantially Equivalent on April 18, 1988. The device falls under product code KEJ (Stages, Microscope), a Class I device regulated under 21 CFR 864.3600. Cryodyne Technologies, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 1988
- Date Received
- April 6, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stages, Microscope
- Device Class
- Class I
- Regulation Number
- 864.3600
- Review Panel
- PA
- Submission Type