The following data is part of a premarket notification filed by Ventlab Corp. with the FDA for Ventlab Verify Ii.
| Device ID | K990098 |
| 510k Number | K990098 |
| Device Name: | VENTLAB VERIFY II |
| Classification | Tube, Tracheal (w/wo Connector) |
| Applicant | VENTLAB CORP. PO BOX 4341 Crofton, MD 21114 -4341 |
| Contact | E J Smith |
| Correspondent | E J Smith VENTLAB CORP. PO BOX 4341 Crofton, MD 21114 -4341 |
| Product Code | BTR |
| CFR Regulation Number | 868.5730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-12 |
| Decision Date | 1999-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20889483098636 | K990098 | 000 |