MANIFOLD KIT— 510(k) K780364

Name: FDA 510(k) clearance K780364
Creator: U.S. Food and Drug Administration
Published: 1978-03-30

Substantially Equivalent

Spica, Inc.

FDA 510(k) clearance K780364 for MANIFOLD KIT, Substantially Equivalent on 1978-03-30. Applicant: Spica, Inc.. Device class: 1.

Clearance details

Applicant: Spica, Inc.
Product code: Code CAN
Device class: Class 1
Regulation: 21 CFR 868.2700
Advisory panel: Anesthesiology
Date received: 1978-03-06
Decision date: 1978-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K060265 — REMCORE REMOTE CONTROLLED OXYGEN REGULATOR2006-10-25
K061785 — CYL-FIL OXYGEN SYSTEM2006-09-07
K950777 — OXYGEN REGULATOR1995-04-14

More clearances from Spica, Inc.

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K800801 — ANALGESIA UNITS, OXYGEN & NITRATE DEVICE1980-05-28
K780365 — OXYGEN/NITROUS OXIDE OUTLET1978-03-30

Adverse events under product code CAN

product code CAN

Death: 4
Other: 1
Total: 5

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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