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FDA 510(k)

ULTRAMED 11S601

K-Number: K842801 · 1984-08-01

ApplicantRobert Bosch Corp.
Decision Date1984-08-01
Product CodeIMJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ULTRAMED 11S601 is the device name listed in this FDA 510(k) record. The listed applicant is Robert Bosch Corp.. It received FDA 510(k) clearance on 1984-08-01 under 510(k) number K842801. The device is classified under product code IMJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ULTRAMED 11S601?

ULTRAMED 11S601 is a medical device that received FDA 510(k) clearance on 1984-08-01. The listed applicant is Robert Bosch Corp.. The 510(k) number is K842801.

When did ULTRAMED 11S601 receive FDA 510(k) clearance?

ULTRAMED 11S601 received FDA 510(k) clearance on 1984-08-01, under 510(k) number K842801.

Who is the listed applicant for ULTRAMED 11S601?

The FDA 510(k) record lists Robert Bosch Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRAMED 11S601?

The FDA product code for ULTRAMED 11S601 is IMJ.

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Other records listing Robert Bosch Corp. 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.

K854492ERG 551 ERGOMETER, BICYCLEK854493ERG 555 COUCH ERGOMETERK854491ERG 550 ERGOMETER BICYCLEK853154HV-4K853541SP 4K853271HEARING AID ANALYSIS SYSTEM

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Related Devices (Code: IMJ)

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.

K252963BTL-899TTBTL Industries, Inc.K250376ViVYViatherm Therapeutics, LLCK243112Curapuls 670Enraf-Nonius, B.V.K223620Reprieve by RegenesisTMRegenesis Biomedical, Inc.K182363BTL-703BTL Industries, Inc.K173300ViaTherm BOOSTViatherm Therapeutics, 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.

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