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FDA 510(k)

BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)

K-Number: K050971 · 2005-08-16

ApplicantBiovalve Technologies, Inc.
Decision Date2005-08-16
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) is the device name listed in this FDA 510(k) record. The listed applicant is Biovalve Technologies, Inc.. It received FDA 510(k) clearance on 2005-08-16 under 510(k) number K050971. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)?

BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) is a medical device that received FDA 510(k) clearance on 2005-08-16. The listed applicant is Biovalve Technologies, Inc.. The 510(k) number is K050971.

When did BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) receive FDA 510(k) clearance?

BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) received FDA 510(k) clearance on 2005-08-16, under 510(k) number K050971.

Who is the listed applicant for BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)?

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

What is the FDA product code for BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS)?

The FDA product code for BIOVALVE INSULIN DELIVERY SYSTEMS (BIDS) is LZG.

Related Clinical Trials

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Other records listing Biovalve Technologies, 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.

K051985BIOVALVE MINI-JECT NEEDLEFREE INJECTORK032976BIOVALVE MINIJECT NEEDLE-FREE INJECTION SYSTEM, MODEL FG-01-001

Related Devices (Code: LZG)

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.

K262153Pivot Insulin Delivery SystemModular Medical, Inc.K253534Pivot Insulin Delivery SystemModular MedicalK240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.K241622Extended Reservoir; MiniMed ReservoirMedtronic MinimedK223372Omnipod GO Insulin Delivery DeviceInsulet CorporationK210714Extended ReservoirMedtronic Minimed, Inc.

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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