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510(k) K911650

PEDIA PALS by Pedia Pals, Inc. — Product Code ERA

K911650 is an FDA 510(k) premarket notification submitted by Pedia Pals, Inc. for the device "PEDIA PALS". The FDA issued a decision of Substantially Equivalent on October 17, 1991. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770. Pedia Pals, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1991
Date Received
April 12, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Otoscope
Device Class
Class I
Regulation Number
874.4770
Review Panel
EN
Submission Type

Other clearances by Pedia Pals, Inc.

  • K951040 — BLOOD PRESSURE CUFF 2 (October 31, 1995)
  • K951041 — BLOOD PRESSURE CUFF 3 (October 31, 1995)
  • K951039 — BLOOD PRESSURE CUFF 1 (October 31, 1995)
  • K951049 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951050 — SPECULUM, ENT (S3) (April 17, 1995)
  • K950086 — PEDIA PALS, INCORPORATED (February 7, 1995)

Other clearances for product code ERA

  • K123821 — AIO HD OTOSCOPE (May 17, 2013)
  • K121326 — LANTOS 3D EAR SCANNER (January 25, 2013)
  • K110326 — OSRAM ITOS (October 27, 2011)
  • K945264 — OPTUS OTOSCOPES (February 2, 1996)
  • K955043 — WELCH ALLYN BI-OTOSCOPE (November 14, 1995)
  • K952578 — WELCH ALLY OTOSCOPE (July 10, 1995)
  • K950913 — PERFECT, ENT SET, PRAKTIKANT, DE LUXE (May 12, 1995)
  • K950788 — OTOSCOPE A-34 (May 3, 1995)
  • K951049 — SPECULUM, ENT (S3) (April 17, 1995)
  • K951050 — SPECULUM, ENT (S3) (April 17, 1995)

FDA data resources