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510(k) K181424

PeDIA by Pedia, LLC — Product Code BTC

K181424 is an FDA 510(k) premarket notification submitted by Pedia, LLC for the device "PeDIA". The FDA issued a decision of Substantially Equivalent on September 25, 2018. The device falls under product code BTC (Bag, Reservoir), a Class I device regulated under 21 CFR 868.5320.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2018
Date Received
May 31, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bag, Reservoir
Device Class
Class I
Regulation Number
868.5320
Review Panel
AN
Submission Type

Other clearances for product code BTC

  • K940220 — REBREATHER BAGS (May 27, 1994)
  • K932496 — PRECISION MED PRODUCTS, LTD. BREATHING BAGS (July 16, 1993)
  • K932581 — BREATHING BAGS (July 16, 1993)
  • K932584 — BREATHING BAGS (July 16, 1993)
  • K932191 — BREATHING BAGS (July 2, 1993)
  • K894906 — ANESTHESIA BREATHING BAGS SIZES 1/2, 1,2,3 LITER (September 18, 1989)
  • K880680 — KING SYSTEMS, BREATHING BAG (March 3, 1988)
  • K864822 — VARIDYNE 550, MODELS 12E,12M,24E & 24M SUCTION SYS (January 15, 1987)
  • K841411 — ROLLED NECK W/PLUG (April 18, 1984)
  • K841412 — ROLLED NECK W/TAP (April 18, 1984)

FDA data resources