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FDA 510(k)

FRASER HARLAKE EMERG. CARE SUCTION SYS

K-Number: K841903 · 1984-06-14

ApplicantFraser Harlake, Inc.
Decision Date1984-06-14
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FRASER HARLAKE EMERG. CARE SUCTION SYS is the device name listed in this FDA 510(k) record. The listed applicant is Fraser Harlake, Inc.. It received FDA 510(k) clearance on 1984-06-14 under 510(k) number K841903. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRASER HARLAKE EMERG. CARE SUCTION SYS?

FRASER HARLAKE EMERG. CARE SUCTION SYS is a medical device that received FDA 510(k) clearance on 1984-06-14. The listed applicant is Fraser Harlake, Inc.. The 510(k) number is K841903.

When did FRASER HARLAKE EMERG. CARE SUCTION SYS receive FDA 510(k) clearance?

FRASER HARLAKE EMERG. CARE SUCTION SYS received FDA 510(k) clearance on 1984-06-14, under 510(k) number K841903.

Who is the listed applicant for FRASER HARLAKE EMERG. CARE SUCTION SYS?

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

What is the FDA product code for FRASER HARLAKE EMERG. CARE SUCTION SYS?

The FDA product code for FRASER HARLAKE EMERG. CARE SUCTION SYS is BTA.

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Other records listing Fraser Harlake, Inc. as applicant

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Related Devices (Code: BTA)

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.

K253629Momcozy Nasal Aspirator (BN007)Shenzhen Root Innovation Technology Co., Ltd.K260134Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021)Shenzhen Root Innovation Technology Co., Ltd.K260892Suction Pump (SU-90)Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)Shenzhen Kingboom Technology Co., Ltd.K253107Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)Shenzhen Kingboom Technology Co., Ltd.

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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