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510(k) K101538

HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) by Philips Electronics UK Limited — Product Code HGY

K101538 is an FDA 510(k) premarket notification submitted by Philips Electronics UK Limited for the device "HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP)". The FDA issued a decision of Substantially Equivalent on Nov 5, 2010. The device falls under product code HGY (Pump, Breast, Non-Powered), a Class I device regulated under 21 CFR 884.5150. Philips Electronics UK Limited has 2 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 5, 2010
Date Received
Jun 3, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Pump, Breast, Non-Powered
Device Class
Class I
Regulation Number
884.5150
Review Panel
OB
Submission Type
510(k) Exempt

Other clearances by Philips Electronics UK Limited

  • K100495 — PHILIPS AVENT DIGITAL THERMOMETER SET, MODEL SCH540 (Jun 22, 2010)
  • K090167 — PHILIPS AVENT CLASSIC STAGE 2 AND 3 TEETHER, MODEL SCF882/01, SCF884/01, PHILIPS… (Jun 18, 2009)

Other clearances for product code HGY

  • K032845 — EASY COMFORT DELUXE MANUAL BREAST PUMP, MODEL 1187 (Apr 5, 2004)
  • K013226 — EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT (Dec 20, 2001)
  • K011519 — AMEDA HYGIENIKIT (Aug 15, 2001)
  • K971231 — WHITE RIVER MINI MANUAL BREAST PUMP (May 19, 1997)
  • K962828 — EVERT-IT (Feb 10, 1997)
  • K952034 — MEDELA'S FOOT PUMP (Sep 12, 1995)
  • K952035 — NIPLETTE (Jul 28, 1995)
  • K925738 — WHITE RIVER MANUAL BREAST PUMP (May 4, 1994)
  • K912355 — MOTHERS TOUCH ONE HAND BREAST PUMP (Dec 10, 1993)
  • K902552 — GERBER PRECIOUS CARE ELECTRIC BREAST PUMP (Sep 26, 1990)

FDA data resources

Source: FDA 510(k) database entry for K101538. Report a data issue: hello@regdatalab.com.