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510(k) K850186

POST AURICULAR HEARING AIDS STAR 33PP, 44,55F & by Robert Bosch Corp.

K850186 is an FDA 510(k) premarket notification submitted by Robert Bosch Corp. for the device "POST AURICULAR HEARING AIDS STAR 33PP, 44,55F &". The FDA issued a decision of Substantially Equivalent on March 27, 1985. Robert Bosch Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1985
Date Received
January 18, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Robert Bosch Corp.

  • K854492 — ERG 551 ERGOMETER, BICYCLE (June 16, 1986)
  • K854491 — ERG 550 ERGOMETER BICYCLE (June 16, 1986)
  • K854493 — ERG 555 COUCH ERGOMETER (June 16, 1986)
  • K853154 — HV-4 (March 28, 1986)
  • K853541 — SP 4 (March 28, 1986)
  • K853271 — HEARING AID ANALYSIS SYSTEM (January 16, 1986)
  • K851485 — DEFI 502 (August 29, 1985)
  • K840717 — ECS 502 (August 19, 1985)
  • K851937 — SONOMED 4 (July 17, 1985)
  • K850188 — BOSCH IN THE EAR HEARING AID SUPERSTAR (April 9, 1985)

FDA data resources