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510(k) K960854

SIEMENS SERVO ULTRA NEBULIZER 345 by Pacesetter, Inc. — Product Code CAF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1996
Date Received
March 1, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type

Other clearances by Pacesetter, Inc.

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  • K954551 — DF-1 TERMINAL CAP (December 26, 1995)
  • K952206 — PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING (August 31, 1995)
  • K951950 — PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING (August 31, 1995)
  • K951087 — TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD (June 29, 1995)
  • K950140 — IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069 (April 6, 1995)

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