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510(k) K935441

INFINITECH BREATH EZ by Infinitech, Inc. — Product Code BWN

K935441 is an FDA 510(k) premarket notification submitted by Infinitech, Inc. for the device "INFINITECH BREATH EZ". The FDA issued a decision of Substantially Equivalent on February 7, 1994. The device falls under product code BWN (Table And Attachments, Operating-Room), a Class I device regulated under 21 CFR 878.4950. Infinitech, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 1994
Date Received
November 12, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Table And Attachments, Operating-Room
Device Class
Class I
Regulation Number
878.4950
Review Panel
SU
Submission Type

Other clearances by Infinitech, Inc.

  • K972506 — INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR (October 1, 1997)
  • K971950 — INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER (August 1, 1997)
  • K951627 — INFINITECH HIGH INTENSITY XENON LIGHT SOURCE SYSTEM (October 19, 1995)
  • K931264 — INFINITECH OTOPROBE (March 1, 1994)
  • K931546 — END-IRRIGATING ENDOILLUMINATOR (February 9, 1994)

Other clearances for product code BWN

  • K942699 — AIRFRAME SURGICAL DRAPE SUPPORT (July 13, 1994)
  • K925005 — ISI SELF-SUPPORTING ARM (April 29, 1993)
  • K922288 — HOLDER, PEDIATRIC POSITION (February 10, 1993)
  • K910783 — SHAMPAINE MODEL 3800 OR MURANAKA MODEL OR-604M (April 2, 1991)
  • K902865 — BAUMER SURGICAL TABLE (September 10, 1990)
  • K884558 — IOP ADJUSTABLE STIRRUP (November 17, 1988)
  • K875291 — SPINAL SURGERY FRAME (January 22, 1988)
  • K873272 — ENDOSCOPY TABLE 1532 ENDOSTAR (September 8, 1987)
  • K860177 — ALLEN UNIVERSAL STIRRUP (February 11, 1986)
  • K852332 — TABLE ACCESSORIES, OPERATING ROOM (July 2, 1985)

FDA data resources