Home / 510(k) Clearances / K830173

510(k) K830173

BERA SH 221 BRIAN STEM AUDIOMETER by Jedmed Instrument Co. — Product Code GNJ

K830173 is an FDA 510(k) premarket notification submitted by Jedmed Instrument Co. for the device "BERA SH 221 BRIAN STEM AUDIOMETER". The FDA issued a decision of Substantially Equivalent on May 25, 1983. The device falls under product code GNJ (Antigens, Ha, Echovirus 1-34), a Class I device regulated under 21 CFR 866.3205. Jedmed Instrument Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 25, 1983
Date Received
January 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigens, Ha, Echovirus 1-34
Device Class
Class I
Regulation Number
866.3205
Review Panel
MI
Submission Type

Other clearances by Jedmed Instrument Co.

  • K150248 — ORL Video NasoPharyngo-Larngoscope (July 23, 2015)
  • K132039 — ERGO-FLEX LARYNGO-NASOPHARYNGOSCOPE EF-N AND EF-N SLIM (February 21, 2014)
  • K021750 — LID CHAIN EYELID WEIGHTS (January 27, 2003)
  • K954184 — JED-LIGHT FIBEROPTIC LIGHT SOURCE (November 13, 1995)
  • K944032 — VIDEO SCOPE SYSTEM (LARYNGOSCOPE) (September 15, 1995)
  • K953457 — JEDMED SPECTRUM ENT CABINET (August 11, 1995)
  • K950925 — JEDMED LARYNGEAL SCOPE (August 11, 1995)
  • K950785 — HORTMANN AIRMATIC AIR CALORIC STIMULATOR (June 28, 1995)
  • K950078 — MICROFLOW IRRIGATION SYSTEM (June 21, 1995)
  • K944671 — VIDEO SCOPE SYSTEM (NASOPHARYNGOSCOPE {FLEXIBLE OR RIGID}) (February 7, 1995)

FDA data resources