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FDA 510(k)

X12 STERILE REFLECTIVE MARKER SPHERE

K-Number: K111443 · 2011-09-29

ApplicantPinsco Inc. Dba B & L Engineering
Decision Date2011-09-29
Product CodeOLO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

X12 STERILE REFLECTIVE MARKER SPHERE is the device name listed in this FDA 510(k) record. The listed applicant is Pinsco Inc. Dba B & L Engineering. It received FDA 510(k) clearance on 2011-09-29 under 510(k) number K111443. The device is classified under product code OLO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the X12 STERILE REFLECTIVE MARKER SPHERE?

X12 STERILE REFLECTIVE MARKER SPHERE is a medical device that received FDA 510(k) clearance on 2011-09-29. The listed applicant is Pinsco Inc. Dba B & L Engineering. The 510(k) number is K111443.

When did X12 STERILE REFLECTIVE MARKER SPHERE receive FDA 510(k) clearance?

X12 STERILE REFLECTIVE MARKER SPHERE received FDA 510(k) clearance on 2011-09-29, under 510(k) number K111443.

Who is the listed applicant for X12 STERILE REFLECTIVE MARKER SPHERE?

The FDA 510(k) record lists Pinsco Inc. Dba B & L Engineering as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X12 STERILE REFLECTIVE MARKER SPHERE?

The FDA product code for X12 STERILE REFLECTIVE MARKER SPHERE is OLO.

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Other records listing Pinsco Inc. Dba B & L Engineering 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.

K982425CODA MPX30 MOTION ANALYSIS SYSTEM

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Official Source

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