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510(k) K902954

OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) by Permobil AB — Product Code HFC

K902954 is an FDA 510(k) premarket notification submitted by Permobil AB for the device "OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC)". The FDA issued a decision of Substantially Equivalent on August 23, 1990. The device falls under product code HFC (Aspirator, Endocervical), a Class II device regulated under 21 CFR 884.1050. Permobil AB has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 1990
Date Received
July 5, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Aspirator, Endocervical
Device Class
Class II
Regulation Number
884.1050
Review Panel
OB
Submission Type

Other clearances by Permobil AB

  • K190682 — Explorer Mini (February 27, 2020)
  • K191874 — F5 Corpus VS (October 25, 2019)
  • K143180 — F3 (March 27, 2015)
  • K143014 — F5 (March 25, 2015)
  • K123290 — M300 & M400 (April 17, 2013)
  • K103477 — PERMOBIL M300 / M400 (March 3, 2011)
  • K081964 — K450 POWERED WHEELCHAIR (July 29, 2008)
  • K071650 — C350 POWERED WHEELCHAIR (September 12, 2007)
  • K041219 — ELECTRO (August 4, 2004)
  • K032765 — STREET (January 30, 2004)

Other clearances for product code HFC

  • K974032 — ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY (December 22, 1997)
  • K960263 — CERVICAL MUCOUS ASPIRATION CATHETER (August 29, 1996)
  • K954903 — PEDI VAGINAL ASPIRATOR (April 29, 1996)
  • K954102 — SELECTMUCUS (November 21, 1995)
  • K902242 — ENDOCERVICAL ASPIRATOR (October 9, 1990)
  • K902032 — O. B. PACK IV (September 28, 1990)
  • K895403 — ASPIRETTE ENDOCERVICAL ASPIRATOR (November 29, 1989)
  • K821134 — DC PACK TM (June 22, 1982)
  • K812175 — ENDOCERVICAL ASPIRATOR (September 21, 1981)
  • K801238 — ACCU-PAP T ZONE SAMPLER (August 12, 1980)

FDA data resources