HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB

FDA 510(k) Premarket Notification · Submission K894838 · Applicant: Baxter Healthcare Corp

Public Record 510(k) Submission Decision Date: 1989-09-07 510(k) record compiled from public FDA source records.

Submission Details & Decision

Normalized public record details for 510(k) notification K894838.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K894838

Applicant / Sponsor

Baxter Healthcare Corp

Device Name

HEMODIALYSIS SINGLE PATIENT SYSTEM (SPS) 550 VSB

Product Code

FKP

Decision Date

1989-09-07

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Gastroenterology, Urology (GU)

Clearance Type

Traditional

Third Party Flag

Date Received

1989-07-31

Related Establishments / Registrations

R & D BATTERIES, INC. Registration: 2132111 View Registration
Medivators Inc Registration: 2150060 View Registration
IBT Scientific Registration: 3029754060 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA premarket notification filings. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Information may be outdated or incomplete. Refer to official government source files for critical decisions.