The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Ace/statcheck Ii Co2 Indicator, Ace/statcheck Ii Co2 Indicator Arm Assemby Adult Statcheck Resuscitator With Ace/statche.
| Device ID | K093525 |
| 510k Number | K093525 |
| Device Name: | ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | VENTLAB CORP. 155 BOYCE DRIVE Mocksville, NC 27028 |
| Contact | James A Cochie |
| Correspondent | James A Cochie VENTLAB CORP. 155 BOYCE DRIVE Mocksville, NC 27028 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-16 |
| Decision Date | 2009-12-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20889483109240 | K093525 | 000 |
| 20889483107864 | K093525 | 000 |
| 20889483099268 | K093525 | 000 |
| 20889483097431 | K093525 | 000 |
| 20889483094294 | K093525 | 000 |
| 20889483090685 | K093525 | 000 |