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FDA 510(k)

INSTAVAC II

K-Number: K934976 · 1994-05-02

ApplicantAeros Instruments, Inc.
Decision Date1994-05-02
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

INSTAVAC II is the device name listed in this FDA 510(k) record. The listed applicant is Aeros Instruments, Inc.. It received FDA 510(k) clearance on 1994-05-02 under 510(k) number K934976. 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 INSTAVAC II?

INSTAVAC II is a medical device that received FDA 510(k) clearance on 1994-05-02. The listed applicant is Aeros Instruments, Inc.. The 510(k) number is K934976.

When did INSTAVAC II receive FDA 510(k) clearance?

INSTAVAC II received FDA 510(k) clearance on 1994-05-02, under 510(k) number K934976.

Who is the listed applicant for INSTAVAC II?

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

What is the FDA product code for INSTAVAC II?

The FDA product code for INSTAVAC II is BTA.

Related Clinical Trials

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Other records listing Aeros Instruments, 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.

K952103AEROS ASPIRATORK933902MOBLVAC IIIK932051TOTE-L-VACK926566CARE-E-VAC

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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