FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
K Number: K023793
·
Decision Feb 11, 2003
Classifications
1
FEI Numbers
80
Registration Numbers
80
Same Product Code
207
Applicant Total
20
Review Days
90
Basic Information
- Device Name
- 1ST RESPONSE INTERMEDIATE MANUAL RESUSCITATOR
- K Number
- K023793
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5915
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PORTEX, INC.
- Date Received
- November 13, 2002
- Decision Date
- February 11, 2003
- Product Code
- BTM
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | FDA class 2 | Anesthesiology |
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Other Clearances by PORTEX, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K033080 | PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETER | Mar 10, 2004 | Substantially Equivalent |
| K031057 | PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KIT | Jul 18, 2003 | Substantially Equivalent |
| K014115 | 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX | Feb 27, 2002 | Substantially Equivalent |
| K014073 | HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICE | Feb 13, 2002 | Substantially Equivalent |
| K873992 | LARYNGECTOMY TUBE | Mar 24, 1988 | Substantially Equivalent |
| K874597 | THERMOVENT 600, 1200, T, 02 | Jan 19, 1988 | Substantially Equivalent |
| K862167 | MINI-TRACH KIT | Aug 6, 1986 | Substantially Equivalent |
| K842456 | JET VENTILATION ADAPTOR | Jul 6, 1984 | Substantially Equivalent |
| K833908 | IRRI-CATH | Feb 4, 1984 | Substantially Equivalent |
| K840015 | SWIVEL ADAPTOR W/ALARM PORT | Jan 17, 1984 | Substantially Equivalent |