Atp (Auto Non-Contact Tonometer/Pachymeter)
FDA 510(k) K042831 · Reichert, Inc.
510(k) numberK042831
Submission
- Device name
- Atp (Auto Non-Contact Tonometer/Pachymeter)
- Applicant
- Reichert, Inc.
Depew, NY, US - Received
- October 13, 2004
- Decision date
- October 28, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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Questions and answers
When was Atp (Auto Non-Contact Tonometer/Pachymeter) cleared by the FDA?
Atp (Auto Non-Contact Tonometer/Pachymeter) (K042831) received a 510(k) decision of Substantially Equivalent on October 28, 2004, 15 days after the submission was received.
What is the product code of K042831?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.