FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Luna G3 BPAP System
K Number: K212263
·
Decision Mar 25, 2022
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
459
Applicant Total
10
Review Days
248
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Basic Information
- Device Name
- Luna G3 BPAP System
- K Number
- K212263
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3B Medical, Inc.
- Date Received
- July 20, 2021
- Decision Date
- March 25, 2022
- Product Code
- BZD
- 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 |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | FDA class 2 | Anesthesiology |
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Other Clearances by 3B Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K201620 | Luna® G3 BPAP 25A | Jan 29, 2021 | Substantially Equivalent |
| K200496 | Aer X | Jul 24, 2020 | Substantially Equivalent |
| K160127 | iCodeConnect | Nov 10, 2016 | Substantially Equivalent |
| K153387 | Luna CPAP and Auto CPAP System | Sep 8, 2016 | Substantially Equivalent |
| K141770 | LUNA CPAP AND AUTO-CPAP SYSTEM | Apr 22, 2015 | Substantially Equivalent |
| K133769 | 3B RESMART BPAP 25A, BMC RESMART BPAP 25A | Aug 25, 2014 | Substantially Equivalent |
| K131901 | IVOLVE NASAL MASK, IVOLVE FULL FACE MASK, IVOLVE N2 | Dec 23, 2013 | Substantially Equivalent |
| K132967 | 3B RESMART CPAP AND AUTO CPAP, BMC RESMART CPAP AND AUTO CPAP | Dec 6, 2013 | Substantially Equivalent |
| K131707 | 3B RESMART CPAP AND AUTO CPAP SYSTEMS, BMC RESMART CPAP AND AUTO CPAP SYSTEMS | Aug 22, 2013 | Substantially Equivalent |