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FDA 510(k)

PATIENT FOLLOW-UP COMPUTER (PFC

K-Number: K820402 · 1982-03-12

ApplicantMedical Systems, Inc.
Decision Date1982-03-12
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PATIENT FOLLOW-UP COMPUTER (PFC is the device name listed in this FDA 510(k) record. The listed applicant is Medical Systems, Inc.. It received FDA 510(k) clearance on 1982-03-12 under 510(k) number K820402. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATIENT FOLLOW-UP COMPUTER (PFC?

PATIENT FOLLOW-UP COMPUTER (PFC is a medical device that received FDA 510(k) clearance on 1982-03-12. The listed applicant is Medical Systems, Inc.. The 510(k) number is K820402.

When did PATIENT FOLLOW-UP COMPUTER (PFC receive FDA 510(k) clearance?

PATIENT FOLLOW-UP COMPUTER (PFC received FDA 510(k) clearance on 1982-03-12, under 510(k) number K820402.

Who is the listed applicant for PATIENT FOLLOW-UP COMPUTER (PFC?

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

What is the FDA product code for PATIENT FOLLOW-UP COMPUTER (PFC?

The FDA product code for PATIENT FOLLOW-UP COMPUTER (PFC is DXN.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medical Systems, Inc. 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.

K983273XCT 2000 L PQCT BONE DENSITOMETER

Related Devices (Code: DXN)

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.

K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, Inc.

Official Source

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