FDA 510(k)

SPAG PAK

K-Number: K896608 · 1990-04-09

Decision Date1990-04-09

Product CodeBYL

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SPAG PAK is the device name listed in this FDA 510(k) record. The listed applicant is Viratek, Inc.. It received FDA 510(k) clearance on 1990-04-09 under 510(k) number K896608. The device is classified under product code BYL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPAG PAK?

SPAG PAK is a medical device that received FDA 510(k) clearance on 1990-04-09. The listed applicant is Viratek, Inc.. The 510(k) number is K896608.

When did SPAG PAK receive FDA 510(k) clearance?

SPAG PAK received FDA 510(k) clearance on 1990-04-09, under 510(k) number K896608.

Who is the listed applicant for SPAG PAK?

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

What is the FDA product code for SPAG PAK?

The FDA product code for SPAG PAK is BYL.

Other records listing Viratek, 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.

K882396AEROSOL DELIVERY HOOD K871427(SPAG) MODEL SPAG-2 6000 SERIES K870051SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLE K843717VIRATEK SMALL PARTICLE AEROSOL GENERAT

Related Devices (Code: BYL)

K935126NASCOR IGLOONascor Pty. , Ltd.K905627NASCOR OXYDOMENascor Pty. , Ltd.K895866DIRD INGANT O2 (BIO 2 HOOD)Bird Products Corp.K893714KEYSTONE OXYGEN TENTKeystone Veterinary Supplies, Inc.K893713NOVA OXYGEN TENTNova Health Systems, Inc.K882396AEROSOL DELIVERY HOODViratek, 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.