The following data is part of a premarket notification filed by Zoll Medical Corp. with the FDA for Zoll M Series Ibp Operation; Zoll M Series Temperature Option.
| Device ID | K011865 |
| 510k Number | K011865 |
| Device Name: | ZOLL M SERIES IBP OPERATION; ZOLL M SERIES TEMPERATURE OPTION |
| Classification | Computer, Blood-pressure |
| Applicant | ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 |
| Contact | Paul Dias |
| Correspondent | Paul Dias ZOLL MEDICAL CORP. 32 SECOND AVE. Burlington, MA 01803 |
| Product Code | DSK |
| CFR Regulation Number | 870.1110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-14 |
| Decision Date | 2001-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847946099312 | K011865 | 000 |
| 00847946006518 | K011865 | 000 |
| 00847946006501 | K011865 | 000 |
| 00847946006495 | K011865 | 000 |
| 00847946006488 | K011865 | 000 |
| 00847946006471 | K011865 | 000 |
| 00847946006457 | K011865 | 000 |
| 00847946004910 | K011865 | 000 |
| 00847946004903 | K011865 | 000 |
| 00847946004897 | K011865 | 000 |
| 00847946004873 | K011865 | 000 |
| 00847946004859 | K011865 | 000 |
| 00847946004835 | K011865 | 000 |
| 00847946004828 | K011865 | 000 |
| 00847946004811 | K011865 | 000 |
| 00847946006525 | K011865 | 000 |
| 00847946006532 | K011865 | 000 |
| 00847946006549 | K011865 | 000 |
| 00847946024512 | K011865 | 000 |
| 00847946014773 | K011865 | 000 |
| 00847946014445 | K011865 | 000 |
| 00847946014438 | K011865 | 000 |
| 00847946014421 | K011865 | 000 |
| 00847946014414 | K011865 | 000 |
| 00847946014407 | K011865 | 000 |
| 00847946014391 | K011865 | 000 |
| 00847946013530 | K011865 | 000 |
| 00847946013523 | K011865 | 000 |
| 00847946013509 | K011865 | 000 |
| 00847946013493 | K011865 | 000 |
| 00847946007331 | K011865 | 000 |
| 00847946007324 | K011865 | 000 |
| 00847946004804 | K011865 | 000 |