SPS 1550 SINGLE NEEDLE PATIENT SYSTEM— 510(k) K922757

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K922757 for SPS 1550 SINGLE NEEDLE PATIENT SYSTEM, Substantially Equivalent on 1995-02-13. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant
Baxter Healthcare Corp
Product code
Code FKP
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mcgaw Park, IL, US
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