1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX— 510(k) K014115
Substantially EquivalentPortex, Inc.
FDA 510(k) clearance K014115 for 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX, Substantially Equivalent on 2002-02-27. Applicant: Portex, Inc.. Device class: 2.
Clearance details
- Applicant
- Portex, Inc.
- Product code
- Code BTM
- Device class
- Class 2
- Regulation
- 21 CFR 868.5915
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Keene, NH, US
Recent devices under product code BTM
view allMore clearances from Portex, Inc.
view all- K033080 — PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER
- K031057 — PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT
- K023793 — 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
- K014073 — HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE
- K873992 — LARYNGECTOMY TUBE
Adverse events under product code BTM
product code BTM- Death
- 19
- Other
- 2
- Total
- 21
Source: openFDA MAUDE database, through . 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.