Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

GE SHOULDER SURFACE COIL, CAT. #M1085AN

K-Number: K892235 · 1989-05-11

Decision Date1989-05-11
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE SHOULDER SURFACE COIL, CAT. #M1085AN is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1989-05-11 under 510(k) number K892235. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GE SHOULDER SURFACE COIL, CAT. #M1085AN?

GE SHOULDER SURFACE COIL, CAT. #M1085AN is a medical device that received FDA 510(k) clearance on 1989-05-11. The listed applicant is General Electric Co.. The 510(k) number is K892235.

When did GE SHOULDER SURFACE COIL, CAT. #M1085AN receive FDA 510(k) clearance?

GE SHOULDER SURFACE COIL, CAT. #M1085AN received FDA 510(k) clearance on 1989-05-11, under 510(k) number K892235.

Who is the listed applicant for GE SHOULDER SURFACE COIL, CAT. #M1085AN?

The FDA 510(k) record lists General Electric Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GE SHOULDER SURFACE COIL, CAT. #M1085AN?

The FDA product code for GE SHOULDER SURFACE COIL, CAT. #M1085AN is LNH.

Related Clinical Trials

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.

Other records listing General Electric Co. 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.

View all 254 devices →

Related Devices (Code: LNH)

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.

Official Source

View on FDA Database →

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

↑