Pathfinder
FDA 510(k) K031788 · Massie Research Laboratories, Inc.
510(k) numberK031788
Submission
- Device name
- Pathfinder
- Applicant
- Massie Research Laboratories, Inc.
Pleasanton, CA, US - Received
- June 10, 2003
- Decision date
- September 2, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MXK – Device, Analysis, Anterior Segment
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.1850
- Specialty
- Ophthalmic
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Questions and answers
When was Pathfinder cleared by the FDA?
Pathfinder (K031788) received a 510(k) decision of Substantially Equivalent on September 2, 2004, 450 days after the submission was received.
What is the product code of K031788?
The FDA product code is MXK – Device, Analysis, Anterior Segment, a Class II (moderate risk) device regulated under 21 CFR 886.1850.