510(k) K894736
K894736 is an FDA 510(k) premarket notification submitted by Astro-Med, Inc. for the device "MT96000 PAPER CHART RECORDER". The FDA issued a decision of Substantially Equivalent on December 13, 1989. The device falls under product code DSF (Recorder, Paper Chart), a Class I device regulated under 21 CFR 870.2810. Astro-Med, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 1989
- Date Received
- July 27, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Paper Chart
- Device Class
- Class I
- Regulation Number
- 870.2810
- Review Panel
- CV
- Submission Type