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510(k) K813305

CONPHAR OTOSCOPE by Conphar, Inc. — Product Code ERA

K813305 is an FDA 510(k) premarket notification submitted by Conphar, Inc. for the device "CONPHAR OTOSCOPE". The FDA issued a decision of Substantially Equivalent on Jan 19, 1982. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770. Conphar, Inc. has 121 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 19, 1982
Date Received
Nov 23, 1981
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 Conphar, Inc.

  • K821825 — CONPHAR SILICONE FEEDING TUBE (Aug 10, 1982)
  • K821295 — OLSEN HEGAR NEEDLE HOLDERS (Jun 3, 1982)
  • K821354 — CONPHAR MAYO HEGAR NEEDLE HOLDER (Jun 3, 1982)
  • K821289 — MAYO-HEGAR NEEDLE HOLDER (Jun 3, 1982)
  • K821273 — MAYO SCISSOR STRAIGHT 6 3/4 (May 28, 1982)
  • K821248 — ROCHESTER PEAN FORCEPS (May 28, 1982)
  • K821282 — THUMB DRESSING FORCEPS 5 (May 28, 1982)
  • K821276 — MAYO SCISSOR CURYED 5 1/2 (May 28, 1982)
  • K821285 — SPLINTER FORCEPS 4 1/2 (May 28, 1982)
  • K821290 — LITTAUER SCISSORS 5 1/2 (May 28, 1982)

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 K813305. Report a data issue: hello@regdatalab.com.