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FDA 510(k)

ZIRBLANK-PS AND ZIRBLANK-FS

K-Number: K070045 · 2007-03-26

ApplicantAcucera, Inc.
Decision Date2007-03-26
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZIRBLANK-PS AND ZIRBLANK-FS is the device name listed in this FDA 510(k) record. The listed applicant is Acucera, Inc.. It received FDA 510(k) clearance on 2007-03-26 under 510(k) number K070045. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIRBLANK-PS AND ZIRBLANK-FS?

ZIRBLANK-PS AND ZIRBLANK-FS is a medical device that received FDA 510(k) clearance on 2007-03-26. The listed applicant is Acucera, Inc.. The 510(k) number is K070045.

When did ZIRBLANK-PS AND ZIRBLANK-FS receive FDA 510(k) clearance?

ZIRBLANK-PS AND ZIRBLANK-FS received FDA 510(k) clearance on 2007-03-26, under 510(k) number K070045.

Who is the listed applicant for ZIRBLANK-PS AND ZIRBLANK-FS?

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

What is the FDA product code for ZIRBLANK-PS AND ZIRBLANK-FS?

The FDA product code for ZIRBLANK-PS AND ZIRBLANK-FS is EIH.

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Other records listing Acucera, 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.

K051501ZIRACE

Related Devices (Code: EIH)

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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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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