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FDA 510(k)

BASIC, MEDIAN, DOMINANT, AND VARIO

K-Number: K983552 · 1999-01-07

ApplicantMedela, Inc.
Decision Date1999-01-07
Product CodeBTA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BASIC, MEDIAN, DOMINANT, AND VARIO is the device name listed in this FDA 510(k) record. The listed applicant is Medela, Inc.. It received FDA 510(k) clearance on 1999-01-07 under 510(k) number K983552. 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 BASIC, MEDIAN, DOMINANT, AND VARIO?

BASIC, MEDIAN, DOMINANT, AND VARIO is a medical device that received FDA 510(k) clearance on 1999-01-07. The listed applicant is Medela, Inc.. The 510(k) number is K983552.

When did BASIC, MEDIAN, DOMINANT, AND VARIO receive FDA 510(k) clearance?

BASIC, MEDIAN, DOMINANT, AND VARIO received FDA 510(k) clearance on 1999-01-07, under 510(k) number K983552.

Who is the listed applicant for BASIC, MEDIAN, DOMINANT, AND VARIO?

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

What is the FDA product code for BASIC, MEDIAN, DOMINANT, AND VARIO?

The FDA product code for BASIC, MEDIAN, DOMINANT, AND VARIO is BTA.

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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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