Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Astopad Patient Warming System

K-Number: K202197 · 2020-09-04

ApplicantStihler Electronic GmbH
Decision Date2020-09-04
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Astopad Patient Warming System is the device name listed in this FDA 510(k) record. The listed applicant is Stihler Electronic GmbH. It received FDA 510(k) clearance on 2020-09-04 under 510(k) number K202197. The device is classified under product code DWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Astopad Patient Warming System?

Astopad Patient Warming System is a medical device that received FDA 510(k) clearance on 2020-09-04. The listed applicant is Stihler Electronic GmbH. The 510(k) number is K202197.

When did Astopad Patient Warming System receive FDA 510(k) clearance?

Astopad Patient Warming System received FDA 510(k) clearance on 2020-09-04, under 510(k) number K202197.

Who is the listed applicant for Astopad Patient Warming System?

The FDA 510(k) record lists Stihler Electronic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Astopad Patient Warming System?

The FDA product code for Astopad Patient Warming System is DWJ.

Other records listing Stihler Electronic GmbH 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.

K260278ThermAffyx(TM) Patient Safety System

Related Devices (Code: DWJ)

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.

K261437Mistral-Air® Warming SystemThe Surgical Company International B.V., doing business as TSC LifeK260278ThermAffyx(TM) Patient Safety SystemStihler Electronic GmbHK260903Hot Pink Pad Warming SystemXodus Medical, Inc.K252861Warming SystemHangzhou Tappa Medical Technology Co., Ltd.K251974Arctic Sun Temperature Management System (Model 5000)Medivance, Inc.K242964Celsi WarmerHadleigh Health Technologies

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.

↑