510(k) K971813

EMBLA by Ferguson Medical — Product Code OLV

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: January 16, 1998
Date Received: May 16, 1997
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Standard Polysomnograph With Electroencephalograph
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.

Other clearances by Ferguson Medical

K033153 — DICOM THEATER (April 23, 2004)
K963794 — PUNCTURENEEDLE (March 19, 1998)
K962615 — TUMORLOCALIZER MRI (March 19, 1998)
K972217 — ORTHOPEDIC SCREW SYSTEM (November 20, 1997)
K972219 — ORTHOPEDIC PLATE SYSTEM (November 20, 1997)
K970819 — TARGOBEAM (July 14, 1997)
K970257 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTE (May 22, 1997)
K970258 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMOR (May 22, 1997)
K970280 — FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTE (May 22, 1997)
K960421 — SINUSCAN 102/SINUSPRINT (April 16, 1997)

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