FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFANT PERCUSSOR PA-010
K Number: K842608
·
Decision Jul 23, 1984
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
57
Applicant Total
2
Review Days
18
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Basic Information
- Device Name
- INFANT PERCUSSOR PA-010
- K Number
- K842608
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5665
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Alpha Medical Systems
- Date Received
- July 5, 1984
- Decision Date
- July 23, 1984
- 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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Other Clearances by Alpha Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K842607 | INFANT APNEA BED STIMULATOR AA-010 | Sep 13, 1984 | Substantially Equivalent |