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)

CTR 100L

K-Number: K771978 · 1977-11-23

ApplicantEmi Medical, Inc.
Decision Date1977-11-23
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CTR 100L is the device name listed in this FDA 510(k) record. The listed applicant is Emi Medical, Inc.. It received FDA 510(k) clearance on 1977-11-23 under 510(k) number K771978. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CTR 100L?

CTR 100L is a medical device that received FDA 510(k) clearance on 1977-11-23. The listed applicant is Emi Medical, Inc.. The 510(k) number is K771978.

When did CTR 100L receive FDA 510(k) clearance?

CTR 100L received FDA 510(k) clearance on 1977-11-23, under 510(k) number K771978.

Who is the listed applicant for CTR 100L?

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

What is the FDA product code for CTR 100L?

The FDA product code for CTR 100L is JAK.

Other records listing Emi Medical, 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.

K791429EMISONIC 4290K781936SCANNER-EMI 7020 AND 7020RK781519EMI SIMULATOR REMOTE CONTROL CONSOLEK781051EMISONIC 4201K780995COMPUTERIZED AXIAL TOMOGRAPHYK7809305543 INDEPENDENT VIEWING SYSTEM

View all 13 devices →

Related Devices (Code: JAK)

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.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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.

↑