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510(k) K851746

1-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS. by Artiberia — Product Code ERA

K851746 is an FDA 510(k) premarket notification submitted by Artiberia for the device "1-110 OTOSCOPE SET BATTERY POWERED DIAG. SET 3PCS.". The FDA issued a decision of Substantially Equivalent on May 29, 1985. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770. Artiberia has 78 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1985
Date Received
Apr 25, 1985
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
510(k) Exempt

Other clearances by Artiberia

  • K851745 — 1-100 UNIVERSAL SET OTOSCOPE & LARYNX EXPLORATON B (Aug 29, 1985)
  • K851786 — 27-230 TO 27-234 VARIOUS CAST BREAKERS, WOLF (Jul 9, 1985)
  • K851720 — 1155/1 TO 1162/12 VARIOUS TYPES GUM SCISSORS (Jul 2, 1985)
  • K851721 — 1200/1 TO 1240/15 VARIOUS TYPES OF DENTAL SCALERS (Jul 2, 1985)
  • K851723 — 1300/10 TO 1305/89-92 VARIOUS CUTTING INSTRUMENTS (Jul 2, 1985)
  • K851730 — 2710 TO 2935 VARIOUS PLIERS FOR ORTHODONTICS/PROST (Jul 2, 1985)
  • K851722 — 1285/5 TO 1295 VARIOUS TYPES OF DENTAL EXCAVATORS (Jul 2, 1985)
  • K851719 — 1070/15 TO 1078/17 VARIOUS TYPES NEEDLE HOLDERS (Jul 2, 1985)
  • K851718 — 930/0 TO 950/6 VARIOUS TYPES OF BONE CURETTES (Jul 2, 1985)
  • K851726 — 1760/1 TO 2010/34 VARIOUS DENTAL FILLING INSTRUMEN (Jul 2, 1985)

Other clearances for product code ERA

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

FDA data resources

Source: FDA 510(k) database entry for K851746. Report a data issue: hello@regdatalab.com.