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510(k) K102192

INDISCAL DIGITAL MANOMETER by Baylis Medical Co., Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 2011
Date Received
August 4, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

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  • K073326 — NRG TRANSSEPTAL NEEDLE (May 28, 2008)
  • K072478 — BAYLIS PAIN MANAGEMENT GENERATOR-TD, MODELS: PMG-115-TD AND PMG-230-TD (December 19, 2007)

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