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)

MICRO-TEMP PUMPS & MICRO-TEMP PADS

K-Number: K843146 · 1984-08-17

ApplicantSeabrook Medical Systems, Inc.
Decision Date1984-08-17
Product CodeILO
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

MICRO-TEMP PUMPS & MICRO-TEMP PADS 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 1984-08-17 under 510(k) number K843146. The device is classified under product code ILO. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO-TEMP PUMPS & MICRO-TEMP PADS?

MICRO-TEMP PUMPS & MICRO-TEMP PADS is a medical device that received FDA 510(k) clearance on 1984-08-17. The listed applicant is Seabrook Medical Systems, Inc.. The 510(k) number is K843146.

When did MICRO-TEMP PUMPS & MICRO-TEMP PADS receive FDA 510(k) clearance?

MICRO-TEMP PUMPS & MICRO-TEMP PADS received FDA 510(k) clearance on 1984-08-17, under 510(k) number K843146.

Who is the listed applicant for MICRO-TEMP PUMPS & MICRO-TEMP PADS?

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 MICRO-TEMP PUMPS & MICRO-TEMP PADS?

The FDA product code for MICRO-TEMP PUMPS & MICRO-TEMP PADS is ILO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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: ILO)

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.

K213097Armory MotionPain Management Technologies, Inc.K083008COOLSKINElbio Co., Ltd.K073675T-PUMP LOCALIZED TEMPERATURE THERAPY PUMPGaymar Industries, Inc.K072152JUNIPER CLN1 DERMAL COOLING DEVICEJuniper Medical, Inc.K070402MODIFICATION TO POLAR CARE 500Breg, Inc.K040317IVC SYSTEMMark H. Friedman

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.

↑