FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ROTARY COMMUNICATION SCANNER MODEL 7010
K Number: K901030
·
Decision Mar 13, 1990
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
37
Applicant Total
4
Review Days
7
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Basic Information
- Device Name
- ROTARY COMMUNICATION SCANNER MODEL 7010
- K Number
- K901030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.3710
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Applicant
- Baylor Biomedical Services
- Date Received
- March 6, 1990
- Decision Date
- March 13, 1990
- Product Code
- ILQ
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ILQ | System, Communication, Powered | FDA class 2 | Physical Medicine |
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