Anesthesiology
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- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
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- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
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- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
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Goniometer, Nonpowered
- Page Type
- Product Code
- Regulation Medical Specialty
- Orthopedic
- Review Panel
- Neurology
- Submission Type
- 510(K) Exempt
- Device Classification
- Class 1
- Regulation Number
- 888.1520
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Eligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
CFR § 888.1520 Nonpowered goniometer
§ 888.1520 Nonpowered goniometer.
(a) Identification. A nonpowered goniometer is a mechanical device intended for medical purposes to measure the range of motion of joints.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
[52 FR 33702, Sept. 4, 1987, as amended at 66 FR 38815, July 25, 2001]