FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
K Number: K991627
·
Decision May 17, 1999
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
70
Applicant Total
172
Review Days
6
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- WALLABY 3 PHOTOTHERAPY SYSTEM, MODEL 3600
- K Number
- K991627
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5700
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Respironics, Inc.
- Date Received
- May 11, 1999
- Decision Date
- May 17, 1999
- Product Code
- LBI
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LBI | Unit, Neonatal Phototherapy | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LBI), ordered by most recent decision date.
SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)
FDA 510(k)
FDA Class 2
·General Hospital
BiliWrap
FDA 510(k)
FDA Class 2
·General Hospital
Infant Phototherapy Equipment
FDA 510(k)
FDA Class 2
·General Hospital
Neonatal Phototherapy System
FDA 510(k)
FDA Class 2
·General Hospital
bili-hut
FDA 510(k)
FDA Class 2
·General Hospital
neoBLUE blanket LED Phototherapy System
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Respironics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243394 | AF531 Oro-Nasal SE Face Mask | Dec 30, 2024 | Substantially Equivalent |
| K231313 | Therapy Mask 3100 NC/SP | Jul 28, 2023 | Substantially Equivalent |
| K210844 | DreamWear Silicone Pillows Mask | Aug 24, 2021 | Substantially Equivalent |
| K210386 | Magneto Nasal Mask | Jul 12, 2021 | Substantially Equivalent |
| K202142 | Sleepware G3 | Oct 29, 2020 | Substantially Equivalent |
| K201439 | Ventilator, Non-continuous (Respirator) | Sep 25, 2020 | Substantially Equivalent |
| K200480 | DreamStation 2 System, DreamStation 2 Advanced System | Jul 10, 2020 | Substantially Equivalent |
| K183226 | Care Orchestrator Essence | Oct 18, 2019 | Substantially Equivalent |
| K183625 | SomnaPatch | Oct 18, 2019 | Substantially Equivalent |
| K181166 | Trilogy Evo | Jul 18, 2019 | Substantially Equivalent |