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)

MINI-TEMP(TM)

K-Number: K881322 · 1988-06-22

ApplicantSeabrook Medical Systems, Inc.
Decision Date1988-06-22
Product CodeDWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MINI-TEMP(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Seabrook Medical Systems, Inc.. It received FDA 510(k) clearance on 1988-06-22 under 510(k) number K881322. 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 MINI-TEMP(TM)?

MINI-TEMP(TM) is a medical device that received FDA 510(k) clearance on 1988-06-22. The listed applicant is Seabrook Medical Systems, Inc.. The 510(k) number is K881322.

When did MINI-TEMP(TM) receive FDA 510(k) clearance?

MINI-TEMP(TM) received FDA 510(k) clearance on 1988-06-22, under 510(k) number K881322.

Who is the listed applicant for MINI-TEMP(TM)?

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

What is the FDA product code for MINI-TEMP(TM)?

The FDA product code for MINI-TEMP(TM) is DWJ.

Other records listing Seabrook Medical Systems, 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.

K952086TROPICAIR CONVECTIVE WARMING BLANKETSK946196TROPICAIR CONVECTIVE WARING SYSTEMK931203COOL-AIDK923104TROPIC-AIRK914182GOLDEN THERMAL(R)K902756TROPI-COOL

View all 12 devices →

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.

K262089Disposable Warming BlanketHangzhou Tappa Medical Technology Co., Ltd.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.

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.

↑