The following data is part of a premarket notification filed by Ge Healthcare Coils (usa Instruments Inc.) with the FDA for Pediatric Positioner Pad Set.
| Device ID | K122174 |
| 510k Number | K122174 |
| Device Name: | PEDIATRIC POSITIONER PAD SET |
| Classification | Cradle, Patient, Radiologic |
| Applicant | GE HEALTHCARE COILS (USA INSTRUMENTS INC.) 1515 DANNER DR Aurora, OH 44202 -9273 |
| Contact | Michelle Huettner |
| Correspondent | Michelle Huettner GE HEALTHCARE COILS (USA INSTRUMENTS INC.) 1515 DANNER DR Aurora, OH 44202 -9273 |
| Product Code | KXH |
| CFR Regulation Number | 892.1830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-23 |
| Decision Date | 2012-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682138130 | K122174 | 000 |