PeDIA— 510(k) K181424

Substantially Equivalent

Pedia, LLC

FDA 510(k) clearance K181424 for PeDIA, Substantially Equivalent on 2018-09-25. Applicant: Pedia, LLC. Device class: 1.

Clearance details

Applicant: Pedia, LLC
Product code: Code BTC
Device class: Class 1
Regulation: 21 CFR 868.5320
Advisory panel: Anesthesiology
Date received: 2018-05-31
Decision date: 2018-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfax, VA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BTC

K940220 — REBREATHER BAGS1994-05-27
K932496 — PRECISION MED PRODUCTS, LTD. BREATHING BAGS1993-07-16
K932581 — BREATHING BAGS1993-07-16
K932584 — BREATHING BAGS1993-07-16
K932191 — BREATHING BAGS1993-07-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.