FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FLUTTER D
K Number: K972859
·
Decision Jun 5, 1998
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
57
Applicant Total
4
Review Days
305
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Basic Information
- Device Name
- FLUTTER D
- K Number
- K972859
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5665
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bradstreet Clinical Research Assoc., Inc.
- Date Received
- August 4, 1997
- Decision Date
- June 5, 1998
- Product Code
- BYI
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BYI | Percussor, Powered-Electric | FDA class 2 | Anesthesiology |
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