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510(k) K853785

SERIES 2000 MEDS MASK by Med Systems — Product Code BSJ

K853785 is an FDA 510(k) premarket notification submitted by Med Systems for the device "SERIES 2000 MEDS MASK". The FDA issued a decision of Substantially Equivalent on December 3, 1985. The device falls under product code BSJ (Mask, Gas, Anesthetic), a Class I device regulated under 21 CFR 868.5550. Med Systems has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1985
Date Received
September 10, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mask, Gas, Anesthetic
Device Class
Class I
Regulation Number
868.5550
Review Panel
AN
Submission Type

Other clearances by Med Systems

  • K201490 — Electro Flo 6 Airway Clearance System (February 12, 2021)
  • K031876 — ELECTRO FLO PERCUSSOR, MODEL 5000 (November 21, 2003)
  • K941145 — OXY-GENERATOR (September 27, 1995)

Other clearances for product code BSJ

  • K163277 — SuperNO2VA Device (October 13, 2017)
  • K953107 — ANESTHESIA/RESPIRATORY FACE MASK (August 15, 1995)
  • K953295 — ANESTHESIA FACE MASK (August 11, 1995)
  • K952689 — BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK (July 11, 1995)
  • K951043 — AIR-SOFT-DISPOSABLE, ANESTHESISA/RESPIRATORY FACE MASK (June 7, 1995)
  • K950771 — DISPOSABLE ADHESIVE FACE MASK (March 10, 1995)
  • K945894 — MASK, GAS, ANESTHETIC (January 27, 1995)
  • K945440 — DISPOSABLE, ANESTHESIA/RESPIRATORY FACE MASK (November 8, 1994)
  • K944157 — DISPOSABLE, PREFORMED FACE MASK (October 3, 1994)
  • K932147 — NON CONDUCTIVE ANESTHESIA FACE MASK,SILICONE (August 20, 1993)

FDA data resources