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)

CASE-II

K-Number: K833458 · 1983-11-14

ApplicantMarquette Electronics, Inc.
Decision Date1983-11-14
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CASE-II is the device name listed in this FDA 510(k) record. The listed applicant is Marquette Electronics, Inc.. It received FDA 510(k) clearance on 1983-11-14 under 510(k) number K833458. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CASE-II?

CASE-II is a medical device that received FDA 510(k) clearance on 1983-11-14. The listed applicant is Marquette Electronics, Inc.. The 510(k) number is K833458.

When did CASE-II receive FDA 510(k) clearance?

CASE-II received FDA 510(k) clearance on 1983-11-14, under 510(k) number K833458.

Who is the listed applicant for CASE-II?

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

What is the FDA product code for CASE-II?

The FDA product code for CASE-II is DPS.

Other records listing Marquette Electronics, 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.

K971868IMPACT (INFORMING MOBILE PERSONNEL AND CARE TRACKING) PAGER SYSTEMK971683WIRELESS LAN (LOCAL AREA NETWORK) - WIRELESS ETHERNETK972199SIGNAL-AVERAGED HIGH RESOLUTION P WAVE ANALYSISK962547CARDIOSERV PK963120RESPONDER 2500 DEFIBRILLATOR AND CARDIAC CARE SYSTEMK962827ALARM DISPLAY UNIT/PAGER-LAN SYSTEM (ADU)

View all 82 devices →

Related Devices (Code: DPS)

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.

K254255S-Patch CardioAIWellysis Corp.K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France Commercial

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.

↑