510(k) K944481
K944481 is an FDA 510(k) premarket notification submitted by Garan Scientific, Inc. for the device "THE HEART PROTECTOR". The FDA issued a decision of Substantially Equivalent on April 10, 1995. The device falls under product code NXB (Dispenser, Solid Medication), a Class I device regulated under 21 CFR 890.5050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 1995
- Date Received
- September 13, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dispenser, Solid Medication
- Device Class
- Class I
- Regulation Number
- 890.5050
- Review Panel
- HO
- Submission Type
A solid medication dispenser is a device intended for medical purposes that is used to issue solid (pills) medication.