Home / 510(k) Clearances / K942244

510(k) K942244

REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE by National Custom Ent., Inc. — Product Code ERA

K942244 is an FDA 510(k) premarket notification submitted by National Custom Ent., Inc. for the device "REPLACEMENT BATTERIES/WELCH ALLYN #72200 POWER HANDLE". The FDA issued a decision of Substantially Equivalent on June 24, 1994. The device falls under product code ERA (Otoscope), a Class I device regulated under 21 CFR 874.4770. National Custom Ent., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1994
Date Received
March 29, 1994
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 National Custom Ent., Inc.

  • K012264 — MARQUETTE MAC8, MAC PERSONAL, MAC STRESS, MODEL N3043IWC (October 10, 2001)
  • K012263 — MARQUETTE EAGLE MONITOR MODEL 4000, MODEL N3024 (October 10, 2001)
  • K012259 — MEDFUSION 2001 & 2010, MODEL N7215IWC (September 12, 2001)
  • K012266 — SHERWOOD 224, 324 FEEDING PUMP & K524 INTRI-FLUSH, MODEL N7213IWC2 (September 12, 2001)
  • K012262 — BAXTER AS40A, AS41 SYRINGE PUMP, MODEL N61WC (September 12, 2001)
  • K012229 — SCALE-TRONIX 48, 2001, 2009,2700,3003,4004, 4800, 5005,5700,6005,6500,6700,6006C (September 10, 2001)
  • K943632 — REPLACEMENT BATTERIES (November 4, 1994)
  • K943680 — NCE REPLACEMENT BATTERIES (November 4, 1994)
  • K942629 — NCE REPLACEMENT BATTERIES (August 18, 1994)
  • K941995 — NCE REPLACEMENT BATTERIES (July 26, 1994)

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