FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
THE HEART PROTECTOR
K Number: K944481
·
Decision Apr 10, 1995
Classifications
1
FEI Numbers
123
Registration Numbers
123
Same Product Code
2
Applicant Total
1
Review Days
209
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Basic Information
- Device Name
- THE HEART PROTECTOR
- K Number
- K944481
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 890.5050
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Garan Scientific, Inc.
- Date Received
- September 13, 1994
- Decision Date
- April 10, 1995
- Product Code
- NXB
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NXB | Dispenser, Solid Medication | FDA class 1 | Physical Medicine |
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