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FDA 510(k)

PM

K-Number: K925980 · 1993-03-24

ApplicantPathfinder Intl. Corp.
Decision Date1993-03-24
Product CodeKNN
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PM is the device name listed in this FDA 510(k) record. The listed applicant is Pathfinder Intl. Corp.. It received FDA 510(k) clearance on 1993-03-24 under 510(k) number K925980. The device is classified under product code KNN. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PM?

PM is a medical device that received FDA 510(k) clearance on 1993-03-24. The listed applicant is Pathfinder Intl. Corp.. The 510(k) number is K925980.

When did PM receive FDA 510(k) clearance?

PM received FDA 510(k) clearance on 1993-03-24, under 510(k) number K925980.

Who is the listed applicant for PM?

The FDA 510(k) record lists Pathfinder Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PM?

The FDA product code for PM is KNN.

Related PubMed Literature

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

PMID: 42745015Lean-Agile Product Development in FDA Relevant and Regulated Medical Device Contexts.Therapeutic innovation & regulatory science ()PMID: 42674147Public transparency and physicochemical standardization in the regulation of PMMA dermal fillers: a comparative analysis of FDA, EU MDR, and ANVISA frameworks.Regulatory toxicology and pharmacology : RTP ()PMID: 42445942R WE ready for reimbursement? A round-up of developments in real-world evidence relating to health technology assessment: part 27.Journal of comparative effectiveness research ()PMID: 42323480Patient Preference Information (PPI) in Medical Device Development: A Cross-Industry Review of Use-Cases.Therapeutic innovation & regulatory science ()

Other records listing Pathfinder Intl. Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K843698CLOSED URINARY DRAINAGE UNIT

Related Devices (Code: KNN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K211919KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKinetic Innovative Seating System, LLCK942309DYNASTY U1-31 (GELL/CELL)Foley & LardnerK942311DYNASTY U1-33 AGMFoley & LardnerK942308DYNASTY GC 12400 (GELL/CELL)Foley & LardnerK942310DYNASTY GC 12550 (GELL/CELL)Foley & LardnerK942312ALDEN LINEAGE WHEELCHAIR CUSHIONLewis W. Ward

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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