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FDA 510(k)

ATMOS E 201 THORAX AND ATMOS S 201 THORAX

K-Number: K103042 · 2011-04-15

ApplicantAtmos, Inc.
Decision Date2011-04-15
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ATMOS E 201 THORAX AND ATMOS S 201 THORAX is the device name listed in this FDA 510(k) record. The listed applicant is Atmos, Inc.. It received FDA 510(k) clearance on 2011-04-15 under 510(k) number K103042. 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 ATMOS E 201 THORAX AND ATMOS S 201 THORAX?

ATMOS E 201 THORAX AND ATMOS S 201 THORAX is a medical device that received FDA 510(k) clearance on 2011-04-15. The listed applicant is Atmos, Inc.. The 510(k) number is K103042.

When did ATMOS E 201 THORAX AND ATMOS S 201 THORAX receive FDA 510(k) clearance?

ATMOS E 201 THORAX AND ATMOS S 201 THORAX received FDA 510(k) clearance on 2011-04-15, under 510(k) number K103042.

Who is the listed applicant for ATMOS E 201 THORAX AND ATMOS S 201 THORAX?

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

What is the FDA product code for ATMOS E 201 THORAX AND ATMOS S 201 THORAX?

The FDA product code for ATMOS E 201 THORAX AND ATMOS S 201 THORAX is BTA.

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 Atmos, 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.

K090130ATMOS S041 WOUNDK090445ATMOS C361/C451 SUCTION PUMP

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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