Apgar-Timer
Apgar-Timer for standard rail (10x25mm)
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
Record
| Listed by | Medela LLC, United States |
|---|---|
| FDA product code | LHB |
| Device type | Timer, Apgar |
| Device class | Class 1 |
| Regulation | 21 CFR 880.2930 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-07 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 017.0015 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CPR Timer | Atom Medical Corporation | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K834129 | 1984-01-10 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.