FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Puffin Lite Infant Resuscitation System
K Number: K182956
·
Decision Jan 18, 2019
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
99
Applicant Total
8
Review Days
86
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Basic Information
- Device Name
- Puffin Lite Infant Resuscitation System
- K Number
- K182956
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.5925
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- International Biomedical
- Date Received
- October 24, 2018
- Decision Date
- January 18, 2019
- Product Code
- BTL
- 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 |
|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | FDA class 2 | Anesthesiology |
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| K221653 | InfaTherm Disposable Infant Warming Mattress | Oct 6, 2022 | Substantially Equivalent |
| K220742 | NxtGen Infant Transport Incubator | Jul 15, 2022 | Substantially Equivalent |
| K193481 | AeroNOx 2.0 Nitric Oxide Titration & Monitoring System | Mar 10, 2020 | Substantially Equivalent |
| K173516 | NuBorne Infant Warmer | Aug 17, 2018 | Substantially Equivalent |
| K160238 | Airborne Phototherapy Light | Jun 14, 2016 | Substantially Equivalent |
| K140707 | LIFEBORNE INFANT RESUSCITATOR | May 28, 2014 | Substantially Equivalent |