PTZ · Class II — Moderate Risk (510(k) clearance required) · Obstetrics/Gynecology · 21 CFR 884.1630
Classification
FDA Product Code
PTZ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 884.1630
Review panel
OB
Medical specialty
Obstetrics/Gynecology
Submission type
4
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
This product code is the class II exempt counterpart of HEX, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 884.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.