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FDA 510(k)

MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) )

K-Number: K942747 · 1994-07-21

ApplicantEngineered Orthopedic Technologies, Inc.
Decision Date1994-07-21
Product CodeKDP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) is the device name listed in this FDA 510(k) record. The listed applicant is Engineered Orthopedic Technologies, Inc.. It received FDA 510(k) clearance on 1994-07-21 under 510(k) number K942747. The device is classified under product code KDP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) )?

MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) is a medical device that received FDA 510(k) clearance on 1994-07-21. The listed applicant is Engineered Orthopedic Technologies, Inc.. The 510(k) number is K942747.

When did MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) receive FDA 510(k) clearance?

MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) received FDA 510(k) clearance on 1994-07-21, under 510(k) number K942747.

Who is the listed applicant for MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) )?

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

What is the FDA product code for MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) )?

The FDA product code for MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) is KDP.

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.

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Other records listing Engineered Orthopedic Technologies, 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.

K874298MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME

Related Devices (Code: KDP)

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.

K013976BOEHRINGER MRI SUCTION REGULATORYBoehringer LaboratoriesK944479PM3300 INTERMITTENT VACUUMPrecision Medical, Inc.K933232BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIEDBoehringer LaboratoriesK926140VACUUM POWER BODY FLUID SUCTION APPARATUSHill-Rom, Inc.K922817PM3000 & PM3100 VACUUM REGULATORPrecision Medical, Inc.K883229OHMEDA CONTINUOUS SUCTION REGULATOROhmeda Medical

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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