FDA 510(k)

SPI-RISE

K-Number: K822359 · 1982-08-27

ApplicantCertified Respiratory Services, Inc.

Decision Date1982-08-27

Product CodeBWF

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

SPI-RISE is the device name listed in this FDA 510(k) record. The listed applicant is Certified Respiratory Services, Inc.. It received FDA 510(k) clearance on 1982-08-27 under 510(k) number K822359. The device is classified under product code BWF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPI-RISE?

SPI-RISE is a medical device that received FDA 510(k) clearance on 1982-08-27. The listed applicant is Certified Respiratory Services, Inc.. The 510(k) number is K822359.

When did SPI-RISE receive FDA 510(k) clearance?

SPI-RISE received FDA 510(k) clearance on 1982-08-27, under 510(k) number K822359.

Who is the listed applicant for SPI-RISE?

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

What is the FDA product code for SPI-RISE?

The FDA product code for SPI-RISE is BWF.

Other records listing Certified Respiratory Services, 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.

K822685NEB-TRAVEL NTS-1000 & NTS-3000 THERAPY

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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.