The following data is part of a premarket notification filed by Cheen Houng Ent. Co. Ltd. with the FDA for 0-20 Cm H20 Peep Valve.
| Device ID | K981415 |
| 510k Number | K981415 |
| Device Name: | 0-20 CM H20 PEEP VALVE |
| Classification | Attachment, Breathing, Positive End Expiratory Pressure |
| Applicant | CHEEN HOUNG ENT. CO. LTD. 23 SAN DREEN ST., ALLEY 11, LANE 65 Taipei (shulin), TW 23805 |
| Contact | Jay Wang |
| Correspondent | Jay Wang CHEEN HOUNG ENT. CO. LTD. 23 SAN DREEN ST., ALLEY 11, LANE 65 Taipei (shulin), TW 23805 |
| Product Code | BYE |
| CFR Regulation Number | 868.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-20 |
| Decision Date | 1998-07-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B0024000PVC0 | K981415 | 000 |
| B0024000PEEP3 | K981415 | 000 |