The following data is part of a premarket notification filed by Ludlow Technical Products with the FDA for Kendall-ltp Disposable Temperature Probes (dtp1,dtp2,dtp3,dtp4).
| Device ID | K964401 |
| 510k Number | K964401 |
| Device Name: | KENDALL-LTP DISPOSABLE TEMPERATURE PROBES (DTP1,DTP2,DTP3,DTP4) |
| Classification | Warmer, Infant Radiant |
| Applicant | LUDLOW TECHNICAL PRODUCTS TWO LUDLOW PARK Chicopee, MA 01022 |
| Contact | Patrick A Malia |
| Correspondent | Patrick A Malia LUDLOW TECHNICAL PRODUCTS TWO LUDLOW PARK Chicopee, MA 01022 |
| Product Code | FMT |
| CFR Regulation Number | 880.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-04 |
| Decision Date | 1997-02-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00694393090986 | K964401 | 000 |
| 15019517071146 | K964401 | 000 |