Assisted Reproduction Laminar Flow Workstation
The Assisted Reproduction Laminar Flow Workstation is a Class 2 obstetrics and gynecology device that is a 510(k)-exempt counterpart of product code MQG, exempted under the 21st Century Cures Act procedures, and does not require premarket notification to market provided it does not exceed the general limitations of exemption found in 21 CFR 884.9. It is regulated under 21 CFR 884.6120 within the Obstetrics/Gynecology medical specialty. The product code is QKH. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- QKH
- Device Class
- FDA class 2
- Regulation Number
- 884.6120
- Medical Specialty
- Obstetrics/Gynecology
- Review Panel
- OB
- Submission Type
- 4
Device Characteristics
Definition
This product code is a class II exempt counterpart of MQG, 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.
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.