SUTTER CPM 5000— 510(k) K830974

Substantially Equivalent

Sutter Biomedical, Inc.

FDA 510(k) clearance K830974 for SUTTER CPM 5000, Substantially Equivalent on 1983-04-12. Applicant: Sutter Biomedical, Inc.. Device class: 1.

Clearance details

Applicant: Sutter Biomedical, Inc.
Product code: Code JFA
Device class: Class 1
Regulation: 21 CFR 890.5410
Advisory panel: Physical Medicine
Date received: 1983-03-28
Decision date: 1983-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JFA

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K921351 — JACE MODEL PM-410 HAND CPM DEVICE1992-05-04
K900794 — MOBILIMB H3 HAND CPM UNIT1990-03-02

More clearances from Sutter Biomedical, Inc.

K875249 — SUTTER PHALANGEAL CAP1988-02-03
K870200 — SUTTER FINGER JOINT PROSTHESIS1987-10-09
K861983 — SUTTER LESSER METATARSAL CAP1986-09-08
K850274 — SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENT1985-04-25
K830649 — SUTTER CPM 20001983-03-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.