510(k) K912929
K912929 is an FDA 510(k) premarket notification submitted by Astro-Med, Inc. for the device "DASH IV". The FDA issued a decision of Substantially Equivalent on August 13, 1991. 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
- August 13, 1991
- Date Received
- July 5, 1991
- 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