The following data is part of a premarket notification filed by Nasorcap Ent., Inc. with the FDA for Nasal/oral 02 Delivery And Gas Sampling Device.
| Device ID | K911970 |
| 510k Number | K911970 |
| Device Name: | NASAL/ORAL 02 DELIVERY AND GAS SAMPLING DEVICE |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | NASORCAP ENT., INC. 1077 HUSTON DR. West Mifflin, PA 15122 |
| Contact | Steven J Derrick |
| Correspondent | Steven J Derrick NASORCAP ENT., INC. 1077 HUSTON DR. West Mifflin, PA 15122 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-03 |
| Decision Date | 1992-08-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 40856824006067 | K911970 | 000 |
| 10856824006066 | K911970 | 000 |
| 10856824006059 | K911970 | 000 |
| 00856824006045 | K911970 | 000 |
| 10856824006035 | K911970 | 000 |
| 00856824006021 | K911970 | 000 |
| 10856824006011 | K911970 | 000 |
| 00856824006007 | K911970 | 000 |