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FDA 510(k)

E-VAC(TM)

K-Number: K862875 · 1986-11-03

ApplicantLaerdal California, Inc.
Decision Date1986-11-03
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

E-VAC(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Laerdal California, Inc.. It received FDA 510(k) clearance on 1986-11-03 under 510(k) number K862875. 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 E-VAC(TM)?

E-VAC(TM) is a medical device that received FDA 510(k) clearance on 1986-11-03. The listed applicant is Laerdal California, Inc.. The 510(k) number is K862875.

When did E-VAC(TM) receive FDA 510(k) clearance?

E-VAC(TM) received FDA 510(k) clearance on 1986-11-03, under 510(k) number K862875.

Who is the listed applicant for E-VAC(TM)?

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

What is the FDA product code for E-VAC(TM)?

The FDA product code for E-VAC(TM) is BTA.

Other records listing Laerdal California, 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.

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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

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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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