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)

PRESSURE STEAM STERILIZERS

K-Number: K895848 · 1989-12-11

ApplicantScientific Device Laboratory, Inc.
Decision Date1989-12-11
Product CodeFLE
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

PRESSURE STEAM STERILIZERS is the device name listed in this FDA 510(k) record. The listed applicant is Scientific Device Laboratory, Inc.. It received FDA 510(k) clearance on 1989-12-11 under 510(k) number K895848. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRESSURE STEAM STERILIZERS?

PRESSURE STEAM STERILIZERS is a medical device that received FDA 510(k) clearance on 1989-12-11. The listed applicant is Scientific Device Laboratory, Inc.. The 510(k) number is K895848.

When did PRESSURE STEAM STERILIZERS receive FDA 510(k) clearance?

PRESSURE STEAM STERILIZERS received FDA 510(k) clearance on 1989-12-11, under 510(k) number K895848.

Who is the listed applicant for PRESSURE STEAM STERILIZERS?

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

What is the FDA product code for PRESSURE STEAM STERILIZERS?

The FDA product code for PRESSURE STEAM STERILIZERS is FLE.

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 Scientific Device Laboratory, 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.

K935316PARASAFE(R) FIXATIVEK924893MICROSPORIDIUM CONTROL SLIDEK911059TURBIDOMETRIC STANDARDK890718GRAM STAIN CONTROL SLIDEK890670CRYPTOSPORIDIUM CONTROL SLIDEK884069SNAP N' STAIN IODINE STAIN

View all 28 devices →

Related Devices (Code: FLE)

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.

K261055AMSCO 700 Steam SterilizerSTERIS CorporationK260254Enbio PROEnbio Group AGK252307Getinge GSS67N Series Steam SterilizerMaquet GmbH (A Getinge Group Company)K250168Life Ultra 25L Tabletop Mono Chamber Steam SterilizerLucas LifecareK250164Cassette Autoclave (ACA5)Guangzhou Ajax Medical Equipment Co., Ltd.K243994Steam Sterilizer (2545D)Ningbo Ican Machines Co., Ltd.

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.

↑