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510(k) K073712

SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 by Adroit Medical Systems, Inc. — Product Code DWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2008
Date Received
December 31, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Thermal Regulating
Device Class
Class II
Regulation Number
870.5900
Review Panel
CV
Submission Type

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

Other clearances by Adroit Medical Systems, Inc.

  • K973981 — SAFEPASS STERILIZATION POUCH (January 29, 1998)
  • K970197 — HTP-1500 LOCALIZED HEAT THERAPY PUMP (September 10, 1997)
  • K962983 — STERILE SOFT-TEMP (January 10, 1997)
  • K921920 — SOFT-TEMP (December 11, 1992)
  • K921928 — SOFT-COVER (November 6, 1992)

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