FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ADR-2000 AMBULATORY DATA RECORDING SYSTEM
K Number: K880977
·
Decision Apr 13, 1988
Classifications
1
FEI Numbers
70
Registration Numbers
70
Same Product Code
74
Applicant Total
2
Review Days
36
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Basic Information
- Device Name
- ADR-2000 AMBULATORY DATA RECORDING SYSTEM
- K Number
- K880977
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Aaron Laboratories, Inc.
- Date Received
- March 8, 1988
- Decision Date
- April 13, 1988
- Product Code
- IKN
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| IKN | Electromyograph, Diagnostic | FDA class 2 | Physical Medicine |
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Other Clearances by Aaron Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880976 | AL-200B MUSCLE ACTIVITY INTEGRATOR | Apr 13, 1988 | Substantially Equivalent |