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FDA 510(k)

BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500

K-Number: K061367 · 2006-08-10

ApplicantBlue Sky Medical Group Incorporated
Decision Date2006-08-10
Product CodeOMP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500 is the device name listed in this FDA 510(k) record. The listed applicant is Blue Sky Medical Group Incorporated. It received FDA 510(k) clearance on 2006-08-10 under 510(k) number K061367. The device is classified under product code OMP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500?

BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500 is a medical device that received FDA 510(k) clearance on 2006-08-10. The listed applicant is Blue Sky Medical Group Incorporated. The 510(k) number is K061367.

When did BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500 receive FDA 510(k) clearance?

BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500 received FDA 510(k) clearance on 2006-08-10, under 510(k) number K061367.

Who is the listed applicant for BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500?

The FDA 510(k) record lists Blue Sky Medical Group Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500?

The FDA product code for BLUESKY VISTA WOUND VACUUM SYSTEM, MODEL 100.0500 is OMP.

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 Blue Sky Medical Group Incorporated 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.

K061919VERSATILE 1 EZCARE WOUND VACUUM SYSTEMK052456MODIFICATION TO VERSATILE 1 WOUND VACUUM SYSTEMK042134VERSATILE 1 WOUND VACUUM SYSTEM

Related Devices (Code: OMP)

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.

K261338RENASYS DYNAFLOW Kit (66807741)Smith & Nephew Medical, Ltd.K253263ConvaVAC™ Negative Pressure Wound Therapy SystemConvatec Limited, Gdc BuildingK253199CURASYS 2 (EMDN0003)CG Bio Co., Ltd.K260646RENASYS EDGE (66803126)Smith & Nephew Medical, Ltd.K261291Nisus NPWT Canister 500-mL (CPC-500)Cork MedicalK254019Wound Geni NPWT SystemBechtel Medical, Inc.

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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