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510(k) K853541

SP 4 by Robert Bosch Corp.

K853541 is an FDA 510(k) premarket notification submitted by Robert Bosch Corp. for the device "SP 4". The FDA issued a decision of SN on March 28, 1986. Robert Bosch Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
March 28, 1986
Date Received
August 26, 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)
  • 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)
  • K850186 — POST AURICULAR HEARING AIDS STAR 33PP, 44,55F & (March 27, 1985)

FDA data resources