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FDA 510(k)

HYPER SAL

K-Number: K070498 · 2007-04-26

ApplicantPari Innovative Manufacturers, Inc.
Decision Date2007-04-26
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

HYPER SAL is the device name listed in this FDA 510(k) record. The listed applicant is Pari Innovative Manufacturers, Inc.. It received FDA 510(k) clearance on 2007-04-26 under 510(k) number K070498. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPER SAL?

HYPER SAL is a medical device that received FDA 510(k) clearance on 2007-04-26. The listed applicant is Pari Innovative Manufacturers, Inc.. The 510(k) number is K070498.

When did HYPER SAL receive FDA 510(k) clearance?

HYPER SAL received FDA 510(k) clearance on 2007-04-26, under 510(k) number K070498.

Who is the listed applicant for HYPER SAL?

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

What is the FDA product code for HYPER SAL?

The FDA product code for HYPER SAL is CAF.

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Other records listing Pari Innovative Manufacturers, 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.

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Related Devices (Code: CAF)

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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