The following data is part of a premarket notification filed by Replacement Parts Industries, Inc. with the FDA for Rpi Skin Or Air Temperature Probe.
| Device ID | K020219 |
| 510k Number | K020219 |
| Device Name: | RPI SKIN OR AIR TEMPERATURE PROBE |
| Classification | Warmer, Infant Radiant |
| Applicant | REPLACEMENT PARTS INDUSTRIES, INC. P.O. BOX 5019 Chatsworth, CA 91313 -5019 |
| Contact | Ira Lapides |
| Correspondent | Ira Lapides REPLACEMENT PARTS INDUSTRIES, INC. P.O. BOX 5019 Chatsworth, CA 91313 -5019 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-22 |
| Decision Date | 2002-04-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841034117339 | K020219 | 000 |
| 00841034103202 | K020219 | 000 |
| 00841034103196 | K020219 | 000 |
| 00841034103189 | K020219 | 000 |
| 00841034103172 | K020219 | 000 |
| 00841034103165 | K020219 | 000 |
| 00841034103158 | K020219 | 000 |
| 00841034103141 | K020219 | 000 |
| 00841034103134 | K020219 | 000 |
| 00841034103219 | K020219 | 000 |
| 00841034103226 | K020219 | 000 |
| 00841034117322 | K020219 | 000 |
| 00841034117315 | K020219 | 000 |
| 00841034117308 | K020219 | 000 |
| 00841034117292 | K020219 | 000 |
| 00841034117285 | K020219 | 000 |
| 00841034117278 | K020219 | 000 |
| 00841034117261 | K020219 | 000 |
| 00841034103233 | K020219 | 000 |
| 00841034103127 | K020219 | 000 |