FDA 510(k)

CLASS II DEVICE FOR I.C.P. MONITORING

K-Number: K822636 · 1982-09-14

ApplicantPhiladelphia Medical Specialties

Decision Date1982-09-14

Product CodeGWM

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

CLASS II DEVICE FOR I.C.P. MONITORING is the device name listed in this FDA 510(k) record. The listed applicant is Philadelphia Medical Specialties. It received FDA 510(k) clearance on 1982-09-14 under 510(k) number K822636. The device is classified under product code GWM. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLASS II DEVICE FOR I.C.P. MONITORING?

CLASS II DEVICE FOR I.C.P. MONITORING is a medical device that received FDA 510(k) clearance on 1982-09-14. The listed applicant is Philadelphia Medical Specialties. The 510(k) number is K822636.

When did CLASS II DEVICE FOR I.C.P. MONITORING receive FDA 510(k) clearance?

CLASS II DEVICE FOR I.C.P. MONITORING received FDA 510(k) clearance on 1982-09-14, under 510(k) number K822636.

Who is the listed applicant for CLASS II DEVICE FOR I.C.P. MONITORING?

The FDA 510(k) record lists Philadelphia Medical Specialties as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLASS II DEVICE FOR I.C.P. MONITORING?

The FDA product code for CLASS II DEVICE FOR I.C.P. MONITORING is GWM.

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Other records listing Philadelphia Medical Specialties as applicant

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Official Source

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