510(k) K820444
K820444 is an FDA 510(k) premarket notification submitted by Medical Equipment Devices, Inc. for the device "HEART-ALERT". The FDA issued a decision of Substantially Equivalent on March 12, 1982. The device falls under product code KHX (Platform, Force-Measuring), a Class I device regulated under 21 CFR 890.1575.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 1982
- Date Received
- February 18, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Platform, Force-Measuring
- Device Class
- Class I
- Regulation Number
- 890.1575
- Review Panel
- PM
- Submission Type