PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MIN— 510(k) K900315

Substantially Equivalent for Some Indications

Percussionaire Corp.

FDA 510(k) clearance K900315 for PERCUSSIONAIRE TXP TRANSPORTER/RESPIRATORS 750 MIN, Substantially Equivalent for Some Indications on 1990-10-26. Applicant: Percussionaire Corp..

Clearance details

Applicant: Percussionaire Corp.
Product code: Code CBK
Advisory panel: Anesthesiology
Date received: 1990-01-22
Decision date: 1990-10-26
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Sandpoint, ID, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CBK

product code CBK

Death: 736
Injury: 3,628
Malfunction: 98,786
Other: 4
Total: 103,154

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.